April 10, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.

As required by 43 CFR 2650.7(d), notice is hereby given that an appealable decision approving lands for conveyance pursuant to the Alaska Native Claims Settlement Act will be issued to Ounalashka Corporation. The lands are in the vicinity of Unalaska, Alaska, and are located in:

The Nuclear Regulatory Commission (NRC) is proposing to add new provisions regarding licensee procedures for responding to notifications of potential aircraft threat and for the mitigation of the loss of large areas of their facilities due to large fires or explosions. These provisions were previously noticed for public comment in the October 26, 2006 (71 FR 62664) proposed power reactor security rulemaking. The NRC is publishing this supplemental proposed rule notice to obtain additional stakeholder feedback on the additional regulatory text that has been added to these provisions since the original proposed rule was published for comment.

This document describes the membership makeup of Federal subsistence regional advisory councils established under subsistence management regulations. This document is the final step in an administrative action with respect to those regulations, made necessary because of an order entered by the U.S. District Court for Alaska. The U.S. District Court order made it necessary to give further consideration to alternative methods for assuring balance in membership for regional advisory councils and to provide a complete and thorough administrative record.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the International Labor Affairs Bureau is soliciting comments concerning the proposed collection regarding the international child labor technical assistance program of the Office of Child Labor, Forced Labor, and Human Trafficking (OCFT). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.

Pursuant to the Council on Environmental Quality Regulations (40 CFR part 1500-08) implementing procedural provisions of the National Environmental Policy Act (NEPA), the Department of Labor, Office of the Secretary (OSEC), in accordance with 29 CFR 11.11(d), gives final notice of the proposed construction of a new Job Corps Center located in Ottumwa, Iowa, and that this construction will not have a significant adverse impact on the environment. In accordance with 29 CFR 11.11(d) and 40 CFR 1501.4(e)(2), a preliminary FONSI for the new Job Corps Center was published in the February 1, 2008 Federal Register (73 FR Page 6209-6210). No comments were received regarding the preliminary FONSI. OSEC has reviewed the conclusion of the environmental assessment (EA), and agrees with the finding of no significant impact. This notice serves as the Final Finding of No Significant Impact for the new Job Corps Center located at College Avenue and 6th Street, Ottumwa, Iowa. The preliminary FONSI and the EA are adopted in final with no change.

Pursuant to the Council on Environmental Quality Regulations (40 CFR part 1500-08) implementing procedural provisions of the National Environmental Policy Act (NEPA), the Department of Labor, Office of the Secretary (OSEC), in accordance with 29 CFR 11.11(d), gives final notice of the proposed construction of a new Job Corps Center located at 4000 Airport Road approximately two miles northwest of Riverton, Wyoming, and that this construction will not have a significant adverse impact on the environment. In accordance with 29 CFR 11.11(d) and 40 CFR 1501.4(e)(2), a preliminary FONSI for the new Job Corps Center was published in the December 12, 2007 Federal Register (72 FR Page 70615-70616). No comments were received that related to the environmental findings of the preliminary FONSI. The Job Corps has reviewed the conclusion of the environmental assessment (EA), and agrees with the finding of no significant impact. This notice serves as the Final Finding of No Significant Impact for the new Job Corps Center located at 4000 Airport Road approximately two miles northwest of Riverton, Wyoming. The preliminary FONSI and the EA are adopted in final with no change.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the new information collection, Forest Landscape Value and Special Place Mapping for National Forest Planning.

The IC Clearance Official, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation, REG-164754-01, Split-Dollar Life Insurance Arrangements.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Revenue Procedure 2002-23, Taxation of Canadian Retirement Plans Under U.S.-Canada Income Tax Treaty.

The New England Fishery Management Council's (Council) Herring Advisory Panel will meet to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Revenue Procedure 99-17, Mark to Market Election for Commodities Dealers and Securities and Commodities Traders.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 12885, Supplement to OF-612, Optional Application for Federal Employment.