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PART 558—NEW ANIMAL DRUGS FOR Authority: 21 U.S.C. 360b, 371. § 558.4 Requirement of a medicated feed
USE IN ANIMAL FEEDS ■ 4. In paragraph (d) of § 558.4, in the mill license.
‘‘Category II’’ table, alphabetically add * * * * *
■ 3. The authority citation for 21 CFR an entry for ‘‘Zilpaterol’’ to read as (d) * * *
part 558 continues to read as follows: follows:
CATEGORY II
Drug Assay limits percent1 Type A Type B maximum (100x) Assay limits percent1 Type B/C2
* * * * * * *
Zilpaterol 90–110 680 g/t (0.075%) 80–110/75–115
1Percent of labeled amount.
2Valuesgiven represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a
Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for
the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.
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Federal Register / Vol. 71, No. 174 / Friday, September 8, 2006 / Rules and Regulations 53007
Dated: August 30, 2006. Pursuant to 1 U.S.C. 112a, the Secretary referenced therein. In particular, if a
Steven D. Vaughn, of State is required to publish annually proposed international agreement
Director, Office of New Animal Drug a compilation of all treaties and embodies a commitment that could
Evaluation, Center for Veterinary Medicine. international agreements to which the reasonably be expected to require (for its
[FR Doc. E6–14898 Filed 9–7–06; 8:45 am] United States is a party that were implementation) the issuance of a
BILLING CODE 4160–01–S signed, proclaimed, or ‘‘with reference ‘‘significant regulatory action’’ (as
to which any other final formality ha[d] defined in section 3 of Executive Order
been executed’’ during the calendar 12866), the agency proposing the
DEPARTMENT OF STATE year. The Secretary of State, however, agreement shall consult in a timely
may determine that certain categories of manner with the OMB regarding such
22 CFR Part 181 agreements should not be published if commitment. This amendment is aimed
certain criteria are met. Any such at ensuring that OMB is apprised of
RIN 1400–AC21 international commitments that may
determination must be published in the
[Public Notice: 5527] Federal Register. have a significant regulatory impact on
Under the second statute, 1 U.S.C. domestic entities or persons prior to the
Publication, Coordination, and 112b, the Secretary of State is required negotiation or conclusion of the
Reporting of International Agreements: to transmit to the Congress the text of international agreement containing the
Amendments any international agreement other than commitment.
A proposed rule on these subjects was
AGENCY: State Department. a treaty to which the United States is a
published in the Federal Register on
party as soon as practicable but no later
ACTION: Final rule. May 18, 2006 (71 FR 28831), which
than 60 days after it enters into force.
contains a more detailed discussion.
SUMMARY: The Department of State is Those agreements that the President
Only one comment was received on the
updating the regulations implementing determines should be classified are to be
proposed regulations. The comment
1 U.S.C. 112a and 112b in order to transmitted, not to Congress as a whole,
supported the proposed amendment to
reflect amendments to the statutes but to the House Committee on
the consultation procedures in 22 CFR
governing publication of U.S. International Relations (at that time
181.4(e) with respect to proposed
international agreements and their called ‘‘the House Committee on
international agreements that reasonably
transmittal to the Congress. It will not Foreign Affairs’’) and to the Senate may result in a ‘‘significant regulatory
be publishing certain categories of Foreign Relations Committee under an action.’’ The commenter expressed the
international agreements in the injunction of secrecy. The statute view that the amendment to the
compilation entitled ‘‘United States further recognizes the Secretary of regulations would ensure a greater level
Treaties and Other International State’s special role in the negotiation of transparency in the negotiation and
Agreements’’ or in the ‘‘Treaties and and conclusion of all U.S. international conclusion of international agreements
Other International Acts Series.’’ agreements, providing that that may lead to significant regulatory
Further, the regulations are being ‘‘[n]otwithstanding any other provision impacts on domestic U.S. entities.
amended to reflect adjustments to of law, an international agreement may Further, the comment made two
certain internal procedures within the not be signed or otherwise concluded on recommendations relating to the
State Department on the reporting of behalf of the United States without prior implementation of the amendment once
international agreements to Congress. consultation with the Secretary of State. it was finalized. First, the commenter
Finally, the Department is adding a new Such consultation may encompass a said that agencies should be required to
requirement concerning procedures for class of agreements rather than a consult with OMB at the earliest
consultation with the Secretary of State particular agreement.’’ possible stage in the discussions of a
in the negotiation and conclusion of The Department of State has issued possible international agreement.
international agreements. Where an regulations to implement these statutory Second, the commenter requested that
international agreement could provisions. These regulations are the State Department require agencies to
reasonably require for its codified in Part 181 of Chapter 22 of the publish a short notice in the Federal
implementation the issuance of a Code of Federal Regulations (CFR). Register when consultation has been
significant domestic regulatory action, Congress has amended both 1 U.S.C. initiated with OMB, asking for public
agencies proposing the agreement are to 112a and 1 U.S.C. 112b several times, comment where appropriate. In the
consult in a timely manner with the most recently in section 7121 of the commenter’s view, such a notice would
Office of Management and Budget Intelligence Reform and Terrorism ensure that the public and other
(OMB), and the Department of State Prevention Act of 2004, Public Law interested agencies are made aware of
should confirm that timely 108–458 (Dec. 17, 2004). The State consultations with OMB, thereby
consultations were undertaken. Department is amending sections of 22 fostering the transparency of an agency’s
DATES: Effective Date: This rule is
CFR Part 181 in order to reflect (1) the development of international
effective October 10, 2006. changes made to 1 U.S.C. 112a and 112b agreements.
in December 2004; (2) certain changes As there has been no objection to the
FOR FURTHER INFORMATION CONTACT: John
made to internal Departmental proposed rule, the State Department
Kim, Assistant Legal Adviser for Treaty procedures; and (3) four additional will promulgate the final rule without
Affairs, Office of the Legal Adviser, categories of international agreements change. The Department nevertheless
Department of State, Washington, DC that meet the non-publication criteria of has considered the commenter’s
20520, 202–647–1660, or at 1 U.S.C. 112a. suggestions. With respect to the first
kimmjj@state.gov. In addition, the Department is suggestion, the Department believes that
rwilkins on PROD1PC63 with RULES
SUPPLEMENTARY INFORMATION: Two amending the procedures regarding the the term ‘‘timely’’ is sufficient to
statutes set forth the Secretary’s unique negotiation and conclusion of indicate the need for agencies to consult
role and important responsibilities in international agreements. These with OMB at an appropriate stage in the
the area of publishing, coordinating, and procedures are set forth in 22 CFR 181.4 discussions concerning proposed
reporting international agreements. and in the Circular 175 procedure international agreements. The
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