August 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information.'' This draft guidance provides recommendations on what chemistry, manufacturing, and controls information sponsors should include regarding reporting, identification, qualification, and setting acceptance criteria for impurities that are classified as degradation products in drug products when submitting an abbreviated new drug application (ANDA) or supplement to support changes in drug substance synthesis or process, formulation of the drug product, the manufacturing process, or components of the container/closure system.

This notice announces the availability, and opportunity for public review and comment, of the environmental assessment (EA) that supports the Department of Energy's (DOE) application to the Department of the Interior, filed with the Bureau of Land Management (BLM), for a Public Land Order to withdraw public lands within and surrounding the Caliente Rail Corridor. As applied for, the withdrawal would preclude surface entry and new mining claim locations for a 20 year period.

NMFS is prohibiting retention of yellowfin sole in the Bering Sea and Aleutian Islands management area (BSAI). NMFS is requiring that catch of yellowfin sole in this area be treated in the same manner as prohibited species and discarded at sea with a minimum of injury. This action is necessary because the 2005 total allowable catch (TAC) of yellowfin sole in the BSAI has been reached.

This notice announces the final decision regarding Self- Determination and Self-Governance language to be negotiated into funding agreements for 2006 regarding fiduciary trust records management. The Federal Register notice published on February 2, 2005 (70 FR 5457) presented a proposed policy on fiduciary trust records management for Self-Determination (Title I) and Self-Governance (Title IV) Tribes/Consortia and language to be negotiated into 2006 Title I and Title IV funding agreements. The February 2, 2005, notice also announced three consultation meetings and an invitation to submit written comments on the proposed policy and funding agreement language. Final Decision: After reviewing numerous comments and suggestions, both written and oral, the Department decided not to institute the proposed policy on fiduciary trust records management for Title I and Title IV Tribes/Consortia; rather, the Department will negotiate with each Tribe/Consortium a specific section in the funding agreement that addresses Tribe's/Consortium's and the Secretary's respective responsibilities regarding the management of fiduciary trust records. This specific section will include the definition of ``fiduciary trust records,'' ``Indian trust assets,'' and ``management.'' The language to be negotiated into the 2006 Title I and Title IV funding agreements regarding fiduciary trust records management is the following and will replace the three options used in the past. The Tribe/Consortium and Secretary agree to the following: The Tribe/Consortium agrees to: (a) Preserve, protect and manage all fiduciary trust records, created and/or maintained by the Tribes/Consortia during their management of trust programs in their Title IV agreements. (A fiduciary trust record is any document that reflects the existence of an Indian trust asset and was used in the management of an Indian trust asset. An Indian trust asset refers to lands, natural resources, monies or other assets held in trust at a particular time by the Federal Government for a Tribe, Alaska natives or that are or were at a particular time restricted against alienation, for individual Indians. Management includes actions that influence, affect, govern, or control an Indian trust asset. The following are examples not considered to be fiduciary trust records: General administrative, personnel or travel records; education records; law enforcement records; health records; law making unrelated to Indian trust assets; tribal council resolutions and laws unrelated to Indian trust assets; and tribal elections.) (b) Make available to the Secretary all fiduciary trust records maintained by the Tribe/Consortium, provided that the Secretary gives reasonable oral or written advance request to the Tribe/Consortium. Access shall include visual inspection and, at the expense of the Secretary, the production of copies (as agreed upon between the parties), and shall not include the removal of the records without tribal approval; and (c) Store and permanently retain all inactive fiduciary trust records at the Tribe/Consortium or allow such records to be removed and stored at the American Indian Records Repository (AIRR) in Lenexa, Kansas, at no cost to the Tribe/Consortium. The Secretary agrees to: (a) Allow the Tribe/Consortium to determine what records it creates to implement the trust programs assumed under its Title IV agreement, except that the Tribe/Consortium must create and maintain the information required by statute and regulation. No additional record keeping requirements are required by this agreement. (b) Store all inactive fiduciary trust records at the American Indian Records Repository (AIRR) at no cost to the Tribe/Consortium when the Tribe/Consortium no longer wishes to keep the records. Further, the Tribe/Consortium will retain legal custody and determine access to these records. Such records shall not be treated as Federal records for purposes of chapter 5 of Title 5 of the United States Code unless expressly agreed to by the Tribe; (c) Create and manage a single tribal storage and retrieval system for all fiduciary trust records stored at AIRR (No records will be accepted at AIRR until such a retrieval system exists); and (d) Provide filing equipment and technical assistance for Tribes/ Consortia in preserving, protecting and managing their fiduciary trust records from available funds appropriated for this purpose. Summary of Comments: The final decision above is the result of a nearly 2-year consultation process by the Department with some Title I and IV Tribes/Consortia. This process included: Conducting pre-scoping telephone conversations with tribal leaders, staff and consultants; holding a scoping meeting as part of a 2-day conference on Indian trust records management at Haskell Indian Nations University; forming a Tribal Fiduciary Trust Records Management Workgroup; conducting four workgroup meetings; transmitting a tribal leader letter soliciting comments on the proposed policy language to be presented for consultation; and engaging in discussions with Tribal leaders and staff at the Fall 2004, Self-Governance Conference. This process culminated with three consultation meetings held in Nashville, Tennessee; Portland, Oregon; and Phoenix, Arizona that were attended by approximately 60 tribal leaders, staff and consultants. In addition, written comments were received from 14 tribes, tribal organizations or tribal consultants some of whom attended the consultation meetings. The comments received can be grouped into the following four major categories: Category 1: New funding agreement language is not needed because existing compact and funding agreement language sufficiently provides for the maintenance of records of trust programs managed by the Tribes/ Consortia, and Tribes/Consortia should not be required to implement a Federal policy on fiduciary trust records management through their funding agreements. The Department respectfully disagrees. The Department believed that the three options available to Tribes/ Consortia in the past are too vague and do not specifically address the Secretary's primary concerns that fiduciary trust records not be destroyed and that the Secretary have the right to access those records if needed in her capacity as trustee delegate. The Department does agree with the comments that a Federal policy does not need to be instituted through the Departmental Manual. Instead the Department has chosen to negotiate language with each Tribe/Consortium into its funding agreement to address fiduciary trust records management. Category 2: The definition of ``fiduciary trust records'' is too broad and vague and the Department should produce a specific list of what fiduciary trust records should be maintained and preserved by the Tribe/Consortium. The definition is purposely broad in recognition of tribal sovereignty. It allows Tribes/Consortia the flexibility to create those records they believe are necessary to properly manage their trust assets through their Title I or Title IV funding agreements. For the Department to create a list of fiduciary trust records would have been both overly restrictive for some Tribes/ Consortia and overly expansive for others. A Department-generated list to be used by all Tribes/Consortia would have been restrictive in that it could deter tribes from creating certain records they feel were appropriate and at the same time it could be expansive by ``requiring'' Tribes/Consortia to create fiduciary trust records they did not believe were necessary for effective management of their trust assets. The Department's concern is that whatever trust records are created be properly protected and available to the Secretary. Category 3: The funding agreement language creates an unfunded mandate because no funding is being provided, and the language requires Tribes/Consortia to maintain record facilities and administer and monitor a records policy. The Department believes that the language proposed for negotiation does not require Tribes/Consortia to create and keep any additional records beyond those they now keep; namely, those that are required by statute or regulation or those records the Tribe/Consortium chooses to create in the management of its own trust resources. The language does not require a tribe to have any other kind of record keeping system other than the ones they currently operate. Before becoming a Title I or Title IV Tribe/Consortium, a Tribe/ Consortium had to demonstrate that it had a functional record keeping system and this language does not expand that requirement. Further, while the language does indicate that Tribes/Consortia are to preserve, protect and manage all fiduciary trust records and that all fiduciary trust records are to be kept permanently, once the Tribe/Consortium chooses that it no longer wants to house their inactive fiduciary trust records at their facility, the Secretary has offered to store those records, at the Secretary's expense, at the American Indian Records Repository. Finally, the Secretary is willing to provide to the Tribes/ Consortia equipment, training and technical assistance, subject to availability of appropriated funds for that purpose. Category 4: A potential problem exists for Tribes/Consortia in storing records at AIRR in that outside interests might gain access to Tribal/Consortium trust records through the Freedom of Information Act because the Tribal/Consortium trust records are held on the Tribe's/ Consortium's behalf by the Department in a Federal facility. To accommodate this concern, language was inserted stating that the Tribe/ Consortium retains legal custody and determines access to those records. Further, language was inserted stating that such records shall not be treated as Federal records for purposes of chapter 5 of Title 5 of the United States Code, unless expressly agreed to by the Tribe.

This rule adjusts the fee for filing appeals of, and motions to reopen or reconsider, any decision under the immigration laws in any type of proceeding other than those described at 8 CFR 1003.1(b), over which the Board of Immigration Appeals (BIA) in the Department of Justice (DOJ) has appellate jurisdiction. The rule also adds a non- substantive modification to the language of the fee regulation in order to enhance clarity. This rule applies to fees for appeals and motions relating to the types of cases under the jurisdiction of the Administrative Appeals Office (AAO). The AAO is an appellate office of U.S. Citizenship and Immigration Services (USCIS). The BIA remains a component of DOJ, and has appellate jurisdiction over the orders of immigration judges, denials of relative immigrant visa petitions (Form I-130), and decisions involving administrative fines and penalties. This rule does not apply to, or affect in any manner, the fees associated with the BIA. Appeals from denials of all other types of applications, such as Applications for Temporary Protected Status (Form I-821), and petitions, such as Petitions for Amerasian, Widow(er), or Special Immigrant (Form I-360), and any subsequently filed motions, are under the jurisdiction of the AAO. The fees, deposited into the Immigration Examinations Fee Account (IEFA), are adjusted from $110 to $385 to recover the full costs associated with the processing of an appeal, motion to reopen or motion to reconsider. Federal statutes authorize USCIS to establish and collect fees to recover the full cost of processing immigration benefit applications, rather than supporting these services with tax revenue. Finally, the rule replaces a reference in the regulations to an obsolete form with a reference to the revised version of that form.

On May 13, 2005, the Ecology Center of Ann Arbor, Michigan, petitioned EPA under section 21 of the Toxic Substances Control Act (TSCA) to establish regulations prohibiting the manufacture, processing, distribution in commerce, use, and improper disposal of lead wheel balancing weights. For the reasons set forth in this notice, EPA has denied the petition to initiate rulemaking. In this notice, the Agency elaborates the reasons for its denial and the type of information it may need.

In accordance with section 113(g) of the Clean Air Act, as amended (``Act''), 42 U.S.C. (7413(g), notice is hereby given of a proposed Consent Decree to address a lawsuit filed by Our Children's Earth Foundation and the Sierra Club (collectively ``Plaintiffs''): Our Children's Earth Found. et al. v. U.S. EPA, No. C 05-00094 CW (N.D. Cal.). On or about January 6, 2005, Plaintiffs filed a complaint alleging that EPA had failed to perform a non-discretionary duty to review and, if appropriate, revise the new source performance standards (``NSPS'') for petroleum refineries and equipment leaks as required by Section 111(b) of the Clean Air Act, 42 U.S.C. 7411(b)(1)(B). Under the terms of the proposed Consent Decree, deadlines are established for EPA to review and, if appropriate, revise the NSPS standards for Subparts J, VV and GGG, 40 CFR 60.100-109, 60.480-498, 60.590-593.

The definition of ``District Director of Customs'' has been amended to reflect the change in title. Also, references to the Customs Service have been changed to the U.S. Customs and Border Protection. A definition has been added for the ``North Atlantic Treaty Organization'' and another definition for ``major non-NATO ally.'' The recordkeeping requirement has been revised to include maintaining records in an electronic format and reproduction of readable documents. No need for multiple copies of supporting documentation for electronic license applications. Also, registration documents are not releasable to the public.

The National Aeronautics and Space Administration, Aeronautics Research Advisory Committee, announces a forthcoming meeting of the Council of Deans Subcommittee.

In accordance with the provisions of the Privacy Act, as amended, this notice announces the renewal of an existing computer matching program that SSA is currently conducting with OPM.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EMSSAB), Idaho National Laboratory. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

The Deputy Secretary of Energy confirmed and approved Rate Order No. WAPA-119 and Rate Schedule SNF-6, placing a non-firm power formula rate from the Stampede Powerplant of the Washoe Project (Stampede) of the Western Area Power Administration (Western) into effect on an interim basis. The provisional formula rate will be in effect until the Federal Energy Regulatory Commission (Commission) confirms, approves, and places it into effect on a final basis or until replaced by other rates. The provisional rate will provide sufficient revenue to pay all annual costs, including interest expense, and repay power investment and irrigation aid, within the allowable periods.

The Administrator, Southwestern Power Administration (Southwestern), has prepared Current and Revised 2005 Power Repayment Studies that show the need for an increase in annual revenues to meet cost recovery criteria. Such increased revenues are required primarily due to significant increases in expected U.S. Army Corps of Engineers' generation investment and increases in operations and maintenance expenses at the project. The Administrator has developed a proposed Robert D. Willis rate schedule, which is supported by a power repayment study, to recover the required revenues. Beginning January 1, 2006, the proposed rates would increase annual revenues approximately 43.1 percent from $452,952 to $648,096.

This final rule modifies NARA facility standards for records storage facilities that house Federal records to clarify requirements relating to design or certification of multiple story facilities and fire detection and protection systems; to revise certain requirements relating to fire-ratings of roofs, building columns, and fire barrier walls; and to clarify the application of other requirements. The rule addresses records center industry concerns identified in the 2003 Report to Congress on Costs and Benefits of Federal Regulations. This rule affects commercial records storage facilities that store Federal records and applies to all agencies, including NARA, that establish and operate records centers, and to agencies that contract for the services of commercial records storage facilities.

The Commander, Eleventh Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Blackpoint Railroad Drawbridge across the Petaluma River, mile 0.8, at Blackpoint, CA. This deviation allows the bridge to remain in the closed-to-navigation position for necessary bridge repair.

The Coast Guard is establishing a temporary safety zone on Lake Michigan, in Milwaukee, WI. This zone is intended to restrict vessels from a portion of Lake Michigan during the Irish Festival Currach Races. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with boat races.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.

The Defense Science Board Task Force on Organizational Structures for Stabilization Operations will meet in open session September 2, 2005, from 1300-1700 at the Pentagon, Room 3E947, Washington, DC. The task force will address organizational structures necessary to support or conduct stability operations. At this meeting, the Defense Science Board Task Force will focus on: (1) What organizational change is needed within OSD Policy, the Joint Staff and the rest of DoD to manage implementationthat is, to ensure that the designated capabilities are created and the interagency and joint vision are followed at various DoD levels; (2) What organizational change is needed within DoD to improve our ability to conduct or support stability operationsincluding employing and integrating DoD capabilities with those of other Departments and Agencies, NGOs, international organizations and the private sector; (3) What should be the timing and sequence of organization change within DoD; (4) What additional staffing is required for any new or reshaped stability operations entities in DoD; and (5) Who the right people are to staff key positions. Members of the public who wish to attend the meeting must contact LTC Dolgoff no later than August 26, 2005, for further information about admission as seating is limited. Additionally, those who wish to make oral comments or deliver written comments should also request to be scheduled, and submit a written text of the comments by August 26, 2005, to allow time for distribution to Task Force members prior to the meeting. Individual oral comments will be limited to five minutes, with the total oral comment period not exceeding 15 minutes. Due to critical mission requirements and the short timeframe to accomplish this review, there was insufficient time to provide timely notice required by section 10(a)(2) of the Federal Advisory Committee Act and subsection 102-3.150(b) of the GSA Final Rule on Federal Advisory Committee Management, 41 CFR 102-3.150(b), which further requires publication at least 15 calendar days prior to the meeting.

As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2005-22184 at https:// dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388.

As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2005-22183 at https:// dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388.