December 6, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing a final order pursuant to the reclassification procedures under the biologics regulations; denying the request by Delmont Laboratories, Inc. (Delmont), for a hearing on FDA's proposal to revoke Delmont's license based on the proposed reclassification of its product, Polyvalent Bacterial Antigens with ``No U.S. Standard of Potency,'' Staphage Lysate[supreg] (SPL) (hereinafter referred to as SPL) into Category II (unsafe, ineffective, or misbranded); and revoking Delmont's U.S. License No. 299. The final order finalizes the proposed order published in the Federal Register of May 15, 2000 (65 FR 31003) (May 2000 proposal), to reclassify Category IIIA bacterial vaccines and bacterial antigens into Category I or Category II.

The Bureau of Indian Affairs published a notice in the Federal Register of October 22, 2010, concerning the Liquor Control Ordinance of the Klamath Tribes. This correction removes incorrect references to an amended ordinance and corrects the effective date of the ordinance.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States.

Pursuant to section 641 of the Tariff Act of 1930, as amended, (19 U.S.C. 1641) and the U.S. Customs and Border Protection regulations (19 CFR 111.45), the following Customs broker license and all associated permits are revoked with prejudice.

This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

The OTS is amending the Federal Register notice published on November 26, 2010, 75 FR 72871. 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 comment on proposed and continuing information collections, as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3507. The Office of Thrift Supervision within the Department of the Treasury will submit the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. Today, OTS is soliciting public comments on its proposal to extend this information collection.

Notice is hereby given that the U.S. International Trade Commission has determined to issue an order dismissing the above- captioned investigation as moot.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Arizona (FEMA-1940-DR), dated 10/04/2010. Incident: Severe Storms and Flooding. Incident Period: 07/20/2010 through 08/07/2010.

This is a Notice of the Presidential declaration of a major disaster for public assistance only for the Territory of the U.S. Virgin Islands (FEMA-1949-DR), dated 11/24/ 2010. Incident: Severe storms, flooding, rockslides, and mudslides associated with Tropical Storm Tomas. Incident Period: 11/08/2010 through 11/12/2010. Effective Date: 11/24/2010. Physical Loan Application Deadline Date: 01/24/2011. Economic Injury (EIDL) Loan Application Deadline Date: 08/24/2011.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010. The guidance document notifies establishments that manufacture whole blood and blood components intended for transfusion about FDA approvals of biologics license applications for serological test systems for the detection of antibodies to Trypanosoma cruzi. These tests are intended for use as donor screening tests to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors. The guidance document does not apply to the collection of source plasma. Also, the guidance does not apply to establishments that make eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/ Ps). The guidance announced in this document finalizes the draft guidance entitled ``Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated March 2009. The recommendations for HCT/P donor screening and testing for T. cruzi antibodies contained in the draft guidance are not being finalized at this time because FDA believes additional discussion is warranted. Elsewhere in this issue of the Federal Register, FDA is publishing a 30-day notice announcing that the proposed collection of information for the guidance has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This notice of waiver concerns two petitions for waiver submitted to the FAA by Space Exploration Technologies Corp. (SpaceX): A petition to waive the requirement that a waiver petition be submitted at least sixty days before the proposed effective date; and a petition to waive the restriction that the combined risk to the public from the launch and reentry of a reentry vehicle not exceed an expected average number of 0.00003 casualties (Ec

Pursuant to Public Law 106-148, the NCGMP Advisory Committee will hold an audio conference call on Wednesday, January 26, 2011, from 1 p.m.-3 p.m. Eastern Standard Time. The Committee will hear updates on progress of the NCGMP toward fulfilling the purposes of the National Geological Mapping Act of 1992; the Federal, State, and education components of the NCGMP; and the National Geological and Geophysical Data Preservation Program.

The Gallatin National Forest's Gallatin County Resource Advisory Committee will meet in Bozeman, Montana. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act. The purpose is of the meeting is to determine parameters and timeframes for the first round of projects and Public Comments.

The Council on Environmental Quality (CEQ) is issuing its final guidance on categorical exclusions. This guidance provides methods for substantiating categorical exclusions, clarifies the process for establishing categorical exclusions, outlines how agencies should engage the public when establishing and using categorical exclusions, describes how agencies can document the use of categorical exclusions, and recommends periodic agency review of existing categorical exclusions. A categorical exclusion is a category of actions that a Federal agency determines does not normally result in individually or cumulatively significant environmental effects. This guidance clarifies the rules for establishing, applying, and revising categorical exclusions. It applies to categorical exclusions established by Federal agencies in accordance with CEQ regulations for implementing the procedural provisions of the National Environmental Policy Act. The guidance was developed to assist agencies in making their implementation of the National Environmental Policy Act (NEPA) more transparent and efficient.

The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is proposing rules to implement new statutory provisions enacted by Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act. These proposed rules apply to the whistleblowers incentives and protection of section 748. The proposed rules establish a whistleblower program that enables the Commission to pay an award, under regulations prescribed by the Commission and subject to certain limitations, to eligible whistleblowers who voluntarily provide the Commission with original information about a violation of the Commodity Exchange Act that leads to the successful enforcement of a covered judicial or administrative action, or a related action. The proposed rules also provide public notice of section 748's prohibition on retaliation by employers against individuals that provide the Commission with information about potential violations.