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15758 Federal Register / Vol. 70, No.

59 / Tuesday, March 29, 2005 / Rules and Regulations

III. Environmental Impact List of Subjects in 21 CFR Part 172 DATES: This rule is effective March 29,
The agency has previously considered 2005.
Food additives, Reporting and
the environmental effects of this rule as recordkeeping requirements. FOR FURTHER INFORMATION CONTACT: Eric
announced in the notice of filing for S. Dubbin, Center for Veterinary
■ Therefore, under the Federal Food, Medicine (HFV–126), Food and Drug
FAP 3A4749 (68 FR 59794). No new
Drug, and Cosmetic Act and under Administration, 7500 Standish Pl.,
information or comments have been
authority delegated to the Commissioner Rockville, MD 20855, 301–827–0232, e-
received that would affect the agency’s
of Food and Drugs, and redelegated to mail: edubbin@cvm.fda.gov.
previous determination that there is no
the Director, Center for Food Safety and SUPPLEMENTARY INFORMATION: Schering-
significant impact on the human
Applied Nutrition, 21 CFR part 172 is Plough Animal Health Corp., 1095
environment and that an environmental
amended as follows: Morris Ave., Union, NJ 07083, filed a
impact statement is not required.
PART 172—FOOD ADDITIVES supplement to NADA 38–233 for
IV. Paperwork Reduction Act of 1995 RALGRO (zeranol), a subcutaneous
PERMITTED FOR DIRECT ADDITION
This final rule contains no collection TO FOOD FOR HUMAN implant used in cattle and in sheep for
of information. Therefore, clearance by CONSUMPTION improved feed efficiency and/or
the Office of Management and Budget increased rate of weight gain. The
under the Paperwork Reduction Act of ■ 1. The authority citation for 21 CFR supplemental NADA provides for the
1995 is not required. part 172 continues to read as follows: establishment of a tolerance for residues
of zeranol in edible tissues of sheep.
V. Objections Authority: 21 U.S.C. 321, 341, 342, 348,
Accordingly, the analytical method for
Any person who will be adversely 371, 379e.
detecting residues of zeranol in
affected by this regulation may file with ■ 2. Section 172.735 is amended by uncooked edible tissues of sheep is
the Division of Dockets Management revising the section heading and the being removed from part 556 (21 CFR
(see ADDRESSES) written or electronic introductory text to read as follows: part 556). The supplemental application
objections (see DATES). Each objection is approved as of March 4, 2005, and the
shall be separately numbered, and each § 172.735 Glycerol ester of wood or gum regulations are amended in § 556.760 to
numbered objection shall specify with rosin. reflect the approval.
particularity the provisions of the Glycerol ester of wood or gum rosin In accordance with the freedom of
regulation to which objection is made may be safely used in food in information provisions of 21 CFR part
and the grounds for the objection. Each accordance with the following 20 and 21 CFR 514.11(e)(2)(ii), a
numbered objection on which a hearing prescribed conditions: summary of safety and effectiveness
is requested shall specifically so state. * * * * * data and information submitted to
Failure to request a hearing for any support approval of this application
particular objection shall constitute a Dated: March 18, 2005.
may be seen in the Division of Dockets
waiver of the right to a hearing on that Leslye M. Fraser, Management (HFA–305), Food and Drug
objection. Each numbered objection for Director, Officer of Regulations and Policy, Administration, 5630 Fishers Lane, rm.
which a hearing is requested shall Center for Food Safety and Applied Nutrition. 1061, Rockville, MD 20852, between 9
include a detailed description and [FR Doc. 05–6089 Filed 3–28–05; 8:45 am] a.m. and 4 p.m., Monday through
analysis of the specific factual BILLING CODE 4160–01–S Friday.
information intended to be presented in The agency has determined under 21
support of the objection in the event CFR 25.33(a)(1) that this action is of a
that a hearing is held. Failure to include DEPARTMENT OF HEALTH AND type that does not individually or
such a description and analysis for any HUMAN SERVICES cumulatively have a significant effect on
particular objection shall constitute a the human environment. Therefore,
waiver of the right to a hearing on the Food and Drug Administration
neither an environmental assessment
objection. Three copies of all documents nor an environmental impact statement
are to be submitted and are to be 21 CFR Part 556
is required.
identified with the docket number Tolerances for Residues of New This rule does not meet the definition
found in brackets in the heading of this Animal Drugs in Food; Zeranol of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
document. Any objections received in it is a rule of ‘‘particular applicability.’’
response to the regulation may be seen AGENCY: Food and Drug Administration, Therefore, it is not subject to the
in the Division of Dockets Management HHS. congressional review requirements in 5
between 9 a.m. and 4 p.m., Monday ACTION: Final rule. U.S.C. 801–808.
through Friday. List of Subjects in 21 CFR Part 556
VI. Reference SUMMARY: The Food and Drug
Administration (FDA) is amending the Animal drugs, Foods.
The following reference has been animal drug regulations to reflect ■ Therefore, under the Federal Food,
placed on display in the Division of approval of a supplemental new animal Drug, and Cosmetic Act and under
Dockets Management (see ADDRESSES) drug application (NADA) filed by authority delegated to the Commissioner
and may be seen by interested persons Schering-Plough Animal Health Corp. of Food and Drugs and redelegated to the
between 9 a.m. and 4 p.m., Monday The supplemental NADA provides for Center for Veterinary Medicine, 21 CFR
through Friday. the establishment of a tolerance for part 556 is amended as follows:
1. Memorandum from D. Doell, FDA, residues of zeranol in edible tissues of
Division of Petition Review, Chemistry PART 556—TOLERANCES FOR
Review Group, and David Carlson, FDA,
sheep. Accordingly, the analytical
RESIDUES OF NEW ANIMAL DRUGS
Division of Petition Review, Toxicology method for detecting residues of zeranol
IN FOOD
Review Group I, to A. Zajac, FDA Division in uncooked edible tissues of sheep is
of Petition Review, Regulatory Review Group being removed from the animal drug ■ 1. The authority citation for 21 CFR
I, February 17, 2005. regulations. part 556 continues to read as follows:

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Federal Register / Vol. 70, No. 59 / Tuesday, March 29, 2005 / Rules and Regulations 15759

Authority: 21 U.S.C. 342, 360b, 371. of Indian Affairs, 400 N. Fifth Street, pursuant to 25 CFR 11.100(a) for the
■ 2. Section 556.760 is amended by Phoenix, Arizona 85004, (602) 379– Western Region to address this law
revising paragraph (b) and by adding 6786; or Ralph Gonzales, Office of enforcement need. This rule merely
paragraph (c) to read as follows: Tribal Services, Bureau of Indian affirms the legitimacy of the
Affairs, 1951 Constitution Avenue, NW., establishment of this court.
§ 556.760 Zeranol. MS 320–SIB, Washington, DC 20240, This final rule will not authorize
* * * * * (202) 513–7629. judges to exercise the following
(b) Tolerances. The tolerances for SUPPLEMENTARY INFORMATION: The authority under 25 CFR part 11: Subpart
residues of zeranol in edible tissues are: authority to issue this rule is vested in E—Civil Actions; Subpart F—Domestic
(1) Cattle. A tolerance is not needed. the Secretary of the Interior by 5 U.S.C. Relations; Subpart G—Probate
(2) Sheep. 20 parts per billion. Proceedings; Subpart I—Children’s
301 and 25 U.S.C. 2 and 9; and 25
(c) Related conditions of use. See Court; and Subpart K—Minor-in-Need-
U.S.C. 13, which authorizes
§ 522.2680 of this chapter. of-Care Procedure.
appropriations for ‘‘Indian judges.’’ See
Dated: March 21, 2005. Tillett v. Hodel, 730 F. Supp., 381 (W.D. Determination To Publish a Direct Final
Steven D. Vaughn, Okla. 1990), aff’d 931 F.2d 636 (10th Rule Effective Immediately
Director, Office of New Animal Drug Cir. 1991), United States v. Clapox, 13 The Bureau of Indian Affairs has
Evaluation, Center for Veterinary Medicine. Sawy. 349, 35 F. 575 (D. Ore. 1888). determined that the public notice and
[FR Doc. 05–6156 Filed 3–28–05; 8:45 am] This rule is published in the exercise of comment provisions of the
BILLING CODE 4160–01–S the rulemaking authority delegated by Administrative Procedure Act, 5 U.S.C.
the Secretary of the Interior to the 553(b), do not apply because of the good
Assistant Secretary—Indian Affairs in cause exception under 5 U.S.C.
DEPARTMENT OF THE INTERIOR the Departmental Manual at 209 DM 8.1. 553(b)(3)(B), which allows the agency to
The territorial jurisdiction is extended suspend the notice and public
Bureau of Indian Affairs to the land described in this document. procedure when the agency finds for
The tract of land located in Nevada, good cause that those requirements are
25 CFR Part 11 within which the Winnemucca Indian impractical, unnecessary and contrary
RIN 1076–AE52
Tribe is located, and more particularly to the public interest. This amendment
described as: will establish a provisional Court of
Law and Order on Indian Reservations (1) That 160 acres set aside by Indian Offenses for the Winnemucca
Executive Order of June 18, 1917, Indian Tribe of Winnemucca, Nevada,
AGENCY: Bureau of Indian Affairs, described as the NE1⁄4 of Section 32, on land that was placed in trust for the
Interior. Township 36 N., Range 38 E., M.D.M.; benefit of the Winnemucca Indian Tribe.
ACTION: Final rule and request for (2) That 160 acres withdrawn by If this provisional court is not
comments. Executive Order of February 8, 1918, established, there is a high potential risk
described as the SE1⁄4 of Section 32, to public safety and a further risk of
SUMMARY: This document adds the Township 36 N., Range 38 E., M.D.M.;
Winnemucca Indian Tribe (Western significant financial liability to the
and Federal Government from a lawsuit for
Region, Nevada) to the listing of Courts (3) That 20 acres acquired by the Acts
of Indian Offenses. This amendment failure to execute diligently its trust
of May 21, 1928 (45 Stat. 618) and May responsibility and provide adequate law
will establish a Court of Indian Offenses 29, 1928 (45 Stat 899) and described as
for a period not to exceed 2 years. It is enforcement on trust land. Delaying this
N1⁄2, NE1⁄4, Section 29, Township 36 N., rule to solicit public comment through
necessary to establish a Court of Indian Range 38 E., M.D.M.
Offenses with jurisdiction over the the proposed rulemaking process would
In addition, the territorial jurisdiction thus be contrary to the public interest.
Winnemucca Indian Tribe of the is extended to any lands hereafter
Winnemucca Reservation and Colony in The Bureau of Indian Affairs Law
acquired by or for the Colony. A Enforcement Services provides Law
order to protect lives and property. provisional Court of Indian Offenses Enforcement Services to the
DATES: This rule is effective on March must be established for the Winnemucca Winnemucca Indian Tribe and an
29, 2005. Comments must be received Indian Tribe to protect the lives, increase in visitors to the Winnemucca
on or before May 31, 2005. Section persons, and property of people residing Reservation and Colony is imminent.
11.100(a)(15) expires March 29, 2007. at and attending or visiting the For these reasons, an immediate
ADDRESSES: You may submit comments, Winnemucca Reservation and Colony, effective date is in the public interest
identified by the number 1076–AE52, by until they establish a tribal court in and in the interest of the Winnemucca
any of the following methods: accordance with 25 CFR 11.100(c). This Tribe. Accordingly, this amendment is
• Federal rulemaking portal: http:// court shall function for a period not to issued as a final rule effective
www.regulations.gov Follow the exceed 2 years. immediately.
instructions for submitting comments. Judges of the Court of Indian Offenses We invite comments on any aspect of
• Fax: (202) 208–5113. shall be authorized to exercise all this rule and we will revise the rule if
• Mail: Ralph Gonzales, Office of authority provided under 25 CFR part comments warrant. Send comments on
Tribal Services, Bureau of Indian 11, including: Subpart D—Criminal this rule to the address in the ADDRESSES
Affairs, 1951 Constitution Avenue, NW., Offenses; Subpart H—Appellate section.
MS 320–SIB, Washington, DC 20240. Proceedings; Subpart J—Juvenile
• Hand delivery: Office of Tribal Offender Procedure; issuance of arrest Regulatory Planning and Review
Services, Bureau of Indian Affairs, 1951 and search warrants pursuant to 25 CFR (Executive Order 12866)
Constitution Avenue, NW., MS 320–SIB, 11.302 and 11.305 and the Indian Law In accordance with the criteria in
Washington, DC 20240. Enforcement Reform Act, 25 U.S.C. Executive Order 12866, this rule is not
FOR FURTHER INFORMATION CONTACT: 2803(2) (1998). Officials of the Bureau of a significant regulatory action. OMB
Sharlot Johnson, Tribal Operations Indian Affairs have already set up a makes the final determination under
Officer, Western Regional Office, Bureau provisional Court of Indian Offenses Executive Order 12866.

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