Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Rules and Regulations 27859 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 558 

[Docket No. FDA–2013–N–0002] 

New Animal Drugs; Change of 

Sponsor’s Name and Address; Change 

of Sponsor 

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’s name and address 

from Purina Mills, Inc., to Purina 

Nutrition LLC, and a change of sponsor 

for a new animal drug application 

(NADA) from Land O’Lakes Purina Feed 

LLC to Purina Nutrition LLC. The 

regulations are also being amended to 

reflect that Zoetis Inc. is a sponsor of 

approved NADAs. 

DATES: This rule is effective May 13, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

Steven D. Vaughn, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8300, 

email: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Purina 

Mills, Inc., P.O. Box 66812, St. Louis, 

MO 63166–6812, has informed FDA that 

it has changed its name and address to 

Purina Nutrition LLC, 1080 County 

Road F West, Shoreview, MN 55126– 

2910. Land O’Lakes Purina Feed LLC, 

has informed FDA that it has transferred 

ownership of, and all rights and interest 

in, NADA 118–509 for Pasture Gainer 

Block 37 R350 and Pasture Gainer Block 

20 R350 to Purina Nutrition LLC. 

Accordingly, the Agency is amending 

the regulations in 21 CFR parts 510 and 

558 to reflect the change of name and 

address and the transfer of ownership. 

In addition, Zoetis Inc. is a sponsor of 

approved NADAs. At this time, FDA is 

amending 21 CFR 510.600 to add 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 558 

Animal drugs, Animal feeds. 

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 558 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), remove the entry for 

‘‘Land O’Lakes Purina Feed LLC’’ and 

‘‘Purina Mills, Inc.’’, and alphabetically 

add entries for ‘‘Purina Nutrition LLC’’ 

and ‘‘Zoetis Inc.’’; and in the table in 

paragraph (c)(2), remove the entry for 

‘‘066071’’, revise the entry for ‘‘017800’’, 

and numerically add an entry for 

‘‘054771’’ 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 

* * * * * 

Purina Nutrition LLC, 1080 

County Road F West, 

Shoreview, MN 55126–2910 ... 017800 

* * * * * 

Zoetis Inc., 333 Portage St., 

Kalamazoo, MI 49007 ............. 054771 

* * * * * 

(2) * * * 

Drug 

labeler 

code 

Firm name and address 

* * * * * 

017800 ... Purina Nutrition LLC, 1080 County Road F West, Shoreview, 

MN 55126–2910. 

* * * * * 

054771 ... Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 

* * * * * 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 3. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.355 [Amended] 

■ 4. In § 558.355, paragraph (f)(7)(iii)(a), 

remove ‘‘066071’’ and add in its place 

‘‘017800’’. 

Dated: May 8, 2013. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2013–11283 Filed 5–10–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

[K00103 12/13 A3A10; 134D0102DR– 

DS5A300000–DR.5A311.IA000113] 

25 CFR Part 162 

RIN 1076–AE73 

Residential, Business, and Wind and 

Solar Resource Leases on Indian Land 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Final rule; correcting 

amendment. 

SUMMARY: The Bureau of Indian Affairs 

(BIA) published a rule in the Federal 

Register of December 5, 2012, 

announcing the revisions to regulations 

addressing non-agricultural surface 

leasing of Indian land. This notice 

makes a minor correction to redesignate 

section numbers for sections that were 

moved to a new subpart. 

DATES: This correction is effective on 

May 13, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Appel, Acting Director, Office 

of Regulatory Affairs & Collaborative 

Action, (202) 273–4680; 

elizabeth.appel@bia.gov. 

SUPPLEMENTARY INFORMATION: 

Need for Correction 

The final regulations (77 FR 72440) 

addressing non-agricultural surface 

leasing of Indian land, and 

redesignating certain sections related to 

agricultural leases, failed to specifically 

redesignate the section numbers of 

sections being moved to subpart F. This 

document corrects that error. 

List of Subjects in 25 CFR Part 162 

Indians—lands. 

Accordingly, 25 CFR part 162 is 

corrected by making the following 

correcting amendment: 


emcdonald on DSK67QTVN1PROD with RULES
27860 Federal Register / Vol. 78, No. 92 / Monday, May 13, 2013 / Rules and Regulations 

PART 162—LEASES and PERMITS 

■ 1. The authority citation continues to 

read as follows: 

Authority: 5 U.S.C. 301, R.S. 463 and 465; 

25 U.S.C. 2 and 9. Interpret or apply sec. 3, 

26 Stat. 795, sec. 1, 28 Stat. 305, secs. 1, 2, 

31 Stat. 229, 246, secs. 7, 12, 34 Stat. 545, 

34 Stat. 1015, 1034, 35 Stat. 70, 95, 97, sec. 

4, 36 Stat. 856, sec. 1, 39 Stat. 128, 41 Stat. 

415, as amended, 751, 1232, sec. 17, 43 Stat. 

636, 641, 44 Stat. 658, as amended, 894, 

1365, as amended, 47 Stat. 1417, sec. 17, 48 

Stat. 984, 988, 49 Stat. 115, 1135, sec. 55, 49 

Stat. 781, sec. 3, 49 Stat. 1967, 54 Stat. 745, 

1057, 60 Stat. 308, secs. 1, 2, 60 Stat. 962, 

sec. 5, 64 Stat. 46, secs. 1, 2, 4, 5, 6, 64 Stat. 

470, 69 Stat. 539, 540, 72 Stat. 968, 107 Stat. 

2011, 108 Stat. 4572, March 20, 1996, 110 

Stat. 4016; 25 U.S.C. 380, 393, 393a, 394, 395, 

397, 402, 402a, 403, 403a, 403b, 403c, 409a, 

413, 415, 415a, 415b, 415c, 415d, 416, 477, 

635, 2201 et seq., 3701, 3702, 3703, 3712, 

3713, 3714, 3715, 3731, 3733, 4211; 44 U.S.C. 

3101 et seq. 

■ 2. Under the heading Subpart F— 

Special Requirements for Certain 

Reservations, redesignate §§ 162.500 

through 162.503, as §§ 162.600 through 

162.603. 

Dated: May 3, 2013. 

Kevin K. Washburn, 

Assistant Secretary—Indian Affairs. 

[FR Doc. 2013–11241 Filed 5–10–13; 8:45 am] 

BILLING CODE 4310–6W–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 799 

[EPA–HQ–OPPT–2005–0033; FRL–9369–1] 

RIN 2070–AD16 

Revocation of TSCA Section 4 Testing 

Requirements for One High Production 

Volume Chemical Substance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This final rule implements 

EPA’s decision to revoke certain testing 

requirements promulgated under the 

Toxic Substance Control Act (TSCA) for 

the High Production Volume (HPV) 

chemical substance, benzenesulfonic 

acid, [[4-[[4-(phenylamino)phenyl][4- 

(phenylimino)-2,5-cyclohexadien-1- 

ylidene]methyl]phenyl]amino]- (CAS 

No. 1324–76–1), also known as C.I. 

Pigment Blue 61. After publication in 

the Federal Register of a final rule 

requiring testing for C.I. Pigment Blue 

61, EPA received adequate, existing 

studies which eliminated the need for 

testing. 

DATES: This final rule is effective June 

12, 2013. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2005–0033, is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Please review the visitor 

instructions and additional information 

about the docket available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Yvonne Gonzalez, Chemical Control 

Division, Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–2912; email address: 

gonzalez.yvonne@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

This action is directed to the public 

in general and may be of particular 

interest to those persons who 

manufacture (defined by statute to 

include import), process, or export the 

chemical substance identified in this 

document. Because other persons may 

also be interested, the Agency has not 

attempted to describe all the specific 

persons that may be affected by this 

action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

II. Background 

A. What action is the Agency taking? 

In this document, EPA is amending 

the TSCA section 4(a) chemical testing 

requirements for one HPV chemical 

substance included in 40 CFR 799.5085. 

Specifically, the amendment revokes 

some of the testing requirements for C.I. 

Pigment Blue 61. EPA bases its decision 

on information (discussed in Unit III.) 

received since publication of the final 

rule (Ref. 1) that established testing 

requirements for this chemical 

substance. 

In the Federal Register issue of March 

16, 2012 (Ref. 2), EPA issued a direct 

final rule revoking some or all of the 

testing requirements for 10 chemical 

substances, including C.I. Pigment Blue 

61. EPA received an adverse comment 

pertaining to a statement in the 

preamble of the direct final rule that 

certain full studies for C.I. Pigment Blue 

61 had been claimed as Confidential 

Business Information (CBI) and were, 

therefore, not available to the public, 

although robust summaries were 

available in the docket. The 

Environmental Defense Fund (EDF) 

objected to EPA’s placing the robust 

summaries in the docket rather than 

applying the disclosure requirements of 

TSCA section 14(b) to the full health 

and safety studies. Consequently, in 

accordance with the procedures 

described in the March 16, 2012 Federal 

Register document (Ref. 2), EPA 

withdrew the revocation of certain 

testing requirements for C.I. Pigment 

Blue 61 in a separate final rule 

document published in the Federal 

Register issue of May 14, 2012 (Ref. 3), 

and also published a proposed rule 

document in the same Federal Register 

issue (Ref. 4) asking for comment. EPA 

is now issuing the final rule based on 

the May 14, 2012 Federal Register 

proposed rule document (Ref. 4). 

B. What is the Agency’s authority for 

taking this action? 

Section 4(a) of TSCA authorizes EPA 

to require testing if certain findings are 

made. The TSCA section 4(a) findings 

include: 

1. The chemical substance was 

produced in substantial quantities. 

2. There are insufficient data upon 

which the effects of manufacture, 

distribution, processing, use, or disposal 

of a chemical substance on health or the 

environment can reasonably be 

determined or predicted. 

3. Testing of the chemical substance 

with respect to such effects is necessary 

to develop such data. (See TSCA section 

4(a)(1)(B)(i), (ii), and (iii); see also 

Ref. 1). 

EPA amends the testing requirements 

for C.I. Pigment Blue 61 because some 

of the findings that EPA made under the 

criteria listed in this unit for this 

chemical substance are no longer 

supported. 

III. Amendment to Chemical Testing 

Requirements 

On July 17, 2006, the Color Pigments 

Manufacturers Association (CPMA) 

submitted a test plan for C.I. Pigment 

Blue 61. CPMA also submitted robust 


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