April 2006 – Federal Register Recent Federal Regulation Documents
Results 451 - 500 of 2,597
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable.'' This guidance is intended to inform sponsors, institutional review boards, clinical investigators, and agency staff that under circumstances described in the guidance, that FDA does not intend to object to the use in device investigations, without informed consent, of leftover human specimens that are not individually identifiable. FDA intends to include in this policy leftover specimens that are remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded, specimens obtained from specimen repositories, and specimens that are leftover from specimens previously collected for other unrelated research. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Draft Recovery Plan for Two Plants From Rota (Nesogenes rotensis
We, the U.S. Fish and Wildlife Service, announce the availability of the Draft Recovery Plan for Two Plants from Rota (Nesogenes rotensis and Osmoxylon mariannense) (no common names) for public review and comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on a 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 two studies of consumer evaluations of variations in content and format of the brief summary in direct-to-consumer (DTC) prescription drug print advertisements.
Environmental Impact Statement: Pellissippi Parkway Extension (State Route 162), Blount County, TN
The Federal Highway Administration (FHWA) is issuing this notice to advise the public that an Environmental Impact Statement (EIS) will be prepared for a proposed highway project in Blount County, Tennessee.
Meeting Notices for the Roseburg District Bureau of Land Management (BLM) Resource Advisory Committee Under Section 205 of the Secure Rural Schools and Community Self Determination Act of 2000 (Pub. L. 106-393).
This notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act. Meeting notice is hereby given for the Roseburg District BLM Resource Advisory Committee pursuant to Section 205 of the Secure Rural Schools and Community Self Determination Act of 2000, Public Law 106-393 (the Act). The committee will convene three times to review, discuss, and recommend funding for project proposals submitted under Title II of the Act. The first meeting will consist of a field trip to past and proposed project locations. At the second meeting, applicants will have an opportunity to make brief presentations regarding their projects. At the third meeting the committee will discuss projects and make funding recommendations. A fourth meeting is scheduled as a contingency, in case the Committee is not able to complete all its work at the previous meetings. At all meetings, a period will be set aside for public comments.
Notification of Citizens Coinage Advisory Committee May 2006 Public Meeting
Pursuant to United States Code, Title 31, section 5135 (b)(8)(C), the United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for May 23, 2006. Date: May 23, 2006. Time: 10 a.m. to 2 p.m. Location: The United States Mint; 801 Ninth Street, NW., Washington, DC; Second floor. Subject: Review of designs for the 2007 First Spouse Bullion Coin Program and other business. Interested persons should call 202-354-7502 for the latest update on meeting time and room location. The CCAC was established to: Advise the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals. Advise the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made. Make recommendations with respect to the mintage level for any commemorative coin recommended.
Navigation Safety Advisory Council
The Navigation Safety Advisory Council (NAVSAC) will meet as required to discuss various issues relating to the safety of navigation. The meeting will be open to the public.
Decision That Nonconforming 2003 Audi RS6 and RS6 Avant Passenger Cars Are Eligible for Importation
This document announces a decision by the National Highway Traffic Safety Administration (NHTSA) that certain 2003 Audi RS6 and RS6 Avant passenger cars that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS) are eligible for importation into the United States because they are substantially similar to vehicles originally manufactured for importation into and sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S. certified version of the 2003 Audi RS6 and RS6 Avant passenger cars), and they are capable of being readily altered to conform to the standards.
Proposed Collection; Comment Request for Regulation Project
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, EE-175-86, (TD 8357), Certain Cash or Deferred Arrangements and Employee and Matching Contributions Under Employee Plans: REG-108639-99 (NPRM) Retirement Plans; Cash or Deferred Arrangements.
Proposed Collection; Comment Request for Form 8876
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 8876, Excise Tax on Structured Settlement Factoring Transactions.
Proposed Collection; Comment Request for Form 14411
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 14411, Systemic Advocacy Issue Submission Form.
Proposed Collection; Comment Request for Form 1041-T
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 1041-T Allocation of Estimated Tax Payments to Beneficiaries.
Proposed Collection; Comment Request for Form 8824
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 8824, Like-Kind Exchanges.
Proposed Collection; Comment Request for Revenue Procedure 2003-39
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 2003-39, section 1031 LKE (Like-Kind Exchanges) Auto Leasing Programs.
Proposed Collection; Comment Request for Revenue Procedure 2003-37
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 2003-37, Documentation Provisions for Certain Taxpayers Using the Fair Market Value Method of Interest Expense Apportionment.
Proposed Collection; Comment Request for Revenue Procedure 97-29
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 97-29, Model Amendments and Prototype Program for SIMPLE IRAs.
Submission for OMB Review; Comment Request
The National Endowment for the Humanities (NEH) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval as required by the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling Susan G. Daisey, Director, Office of Grant Management, the National Endowment for the Humanities (202-606-8494) or may be requested by e-mail to sdaisey@neh.gov. Comments should be sent to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the National Endowment for the Humanities, Office of Management and Budget, Room 10235, Washington, DC 20503 (202-395-7316), within 30 days from the date of this publication in the Federal Register.
List of Drugs for Which Pediatric Studies Are Needed
The National Institutes of Health (NIH) is providing notice of the ``List of Drugs for Which Pediatric Studies Are Needed.'' The NIH developed the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by the Best Pharmaceuticals for Children Act. This list prioritizes certain drugs most in need of study for use by children to ensure their safety and efficacy. The NIH will update the list at least annually until the Act expires on October 1, 2007.
National Toxicology Program (NTP); Office of Chemical Nomination and Selection; Announcement of and Request for Public Comment on Toxicological Study Nominations to the NTP; Clarification
The NTP is issuing a clarification of a Federal Register notice published on April 11, 2006 (Volume 71, Number 69, pages 18341- 18344), because a table summarizing the toxicological study nominations contains several misaligned columns and rows. A correct version of the table is available on the NTP Web site at https://ntp.niehs.nih.gov/go/ 21134 or by contacting Dr. Scott Masten (see ADDRESSES below).
Regulatory Site Visit Training Program; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of April 11, 2006. The document reannounced the invitation for participation in its Regulatory Site Visit Training Program. The document was published with an incorrect e- mail address. This document corrects that error.
Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of March 7, 2006. The document announced a workshop on FDA clinical trial statutory and regulatory requirements. The document was published with an incorrect Internet address. This document corrects that error.
Notice of Information Collection Under OMB Review
The National Aeronautics and Space Administration, 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 (Pub. L. 04-13, 44 U.S.C. 3506(c)(2)(A)).
NASA Advisory Council; Meeting
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the NASA Advisory Council.
Endangered and Threatened Wildlife and Plants: 90-Day Finding on a Petition To List the Siskiyou Mountains Salamander and Scott Bar Salamander as Threatened or Endangered
We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the Siskiyou Mountains salamander (Plethodon stormi) and Scott Bar salamander (Plethodon asupak) as threatened or endangered, under the Endangered Species Act (Act) of 1973, as amended (16 U.S.C. 1531 et seq.). We find that the petition and additional information in our files do not present substantial scientific or commercial information indicating that listing these species may be warranted. We will not be initiating a status review in response to this petition. We ask the public to submit to us any new information that becomes available concerning the status of, or threats to these species.
Fisheries of the Northeastern United States; Monkfish Fishery
NMFS implements measures to establish target total allowable catch (TAC) levels for the monkfish fishery for the 2006 fishing year (FY), and adjusts trip limits and establishes days-at-sea (DAS) restrictions for limited access monkfish vessels fishing in the Southern Fishery Management Area (SFMA) based upon the annual target TAC setting, trip limit, and DAS adjustment methods established in Framework Adjustment 2 (Framework 2) to the Monkfish Fishery Management Plan (FMP). The action is necessary to comply with the rebuilding plan established in the FMP and modified in Framework 2. The intent of this action is to help eliminate overfishing and rebuild the monkfish resource in accordance with Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requirements.
Fisheries of the Exclusive Economic Zone Off Alaska; Yellowfin Sole by Vessels Using Trawl Gear in Bering Sea and Aleutian Islands Management Area
NMFS is closing directed fishing for yellowfin sole by vessels using trawl gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the second seasonal allowance of the 2006 halibut bycatch allowance specified for the trawl yellowfin sole fishery category in the BSAI.
Oil and Gas and Sulphur Operations in the Outer Continental Shelf (OCS), 30 CFR 250 Subpart A, General-Data Release and Definitions
This final rule will revise certain existing definitions, clarify the basis upon which the Regional Director invokes the requirement for an archaeological survey on a lease area, add notification requirements on production status of wells, and update both public information and Information Collection sections. MMS recently redesigned and renamed some of its forms to streamline data submission. MMS also discovered inconsistent practices in first production reporting, which is a prime parameter in determining inspection and testing schedules for safety system devices. This final rulemaking will update the regulations to correspond to recently revised forms, provide clarity and explanation of definitions and forms, and clarify the requirements for first production notices.
Notice of Open Special Meeting of the Sub-Saharan Africa Advisory Committee (SAAC) of the Export-Import Bank of the United States (Export-Import Bank)
The sub-Saharan Africa Advisory Committee was established by Pub. L. 105-121, November 26, 1997, to advise the Board of Directors on the development and implementation of policies and programs designed to support the expansion of the Bank's financial commitments in Sub- Saharan Africa under the loan, guarantee and insurance programs of the Bank. Further, the committee shall make recommendations on how the Bank can facilitate greater support by U.S. commercial banks for trade with Sub-Saharan Africa.
Meeting of the Yakima River Basin Conservation Advisory Group, Yakima River Basin Water Enhancement Project, Yakima, WA
As required by the Federal Advisory Committee Act, notice is hereby given that the Yakima River Basin Conservation Advisory Group, Yakima River Basin Water Enhancement Project, Yakima, Washington, established by the Secretary of the Interior, will hold a public meeting. The purpose of the Conservation Advisory Group is to provide technical advice and counsel to the Secretary of the Interior and Washington State on the structure, implementation, and oversight of the Yakima River Basin Water Conservation Program.
Notice of Public Meeting: Resource Advisory Council to the Boise District, Bureau of Land Management, U.S. Department of the Interior
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Boise District Resource Advisory Council (RAC), will meet as indicated below.
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