May 22, 2006 – Federal Register Recent Federal Regulation Documents

The United States Patent and Trademark Office (USPTO), 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 the new information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing the withdrawal of an amendment to the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to and additions of regulations regarding coal combustion by-products and coal combustion products. Texas intended to revise its program to clarify how the use and disposal of coal combustion by-products and coal combustion products are regulated at coal mine sites in Texas. By letter dated April 11, 2006, Texas withdrew the amendment at its own initiative.

This notice advises the public that the North Carolina Wildlife Resources Commission (NCWRC, or Applicant) has applied to the Fish and Wildlife Service (Service) for an enhancement of survival permit (ESP) under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (Act). The ESP application includes a proposed Safe Harbor Agreement (SHA) for the endangered Red-cockaded Woodpecker (Picoides borealis) (RCW) for a period of 99 years, along with a supporting Environmental Assessment (EA). We announce the opening of a 30-day comment period and request comments from the public on the proposed SHA and the supporting EA.

The U.S. Naval Academy Board of Visitors will meet to make such inquiry, as the Board shall deem necessary into the state of morale and discipline, the curriculum, instruction, physical equipment, fiscal affairs, and academic methods of the Naval Academy. The meeting will include discussions of personnel issues at the Naval Academy, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. The executive session of this meeting will be closed to the public.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q8 Pharmaceutical Development.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.

Notice is hereby given that, pursuant to Title 19 of the Code of Federal Regulations 111.51(a), the following individual Customs broker licenses and any and all permits have been cancelled due to the death of the broker:

The National Park Service (NPS) has revised existing policies and procedures that guide its acceptance of donations and its relationships to those who desire to raise private sector support to benefit parks and programs. The policies and procedures apply to all units of the national park system, and supersede and replace the policies and procedures originally issued in 1998 that were subsequently extended pending the completion of the revision.

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 Notice 2000-28, Coal Exports.

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 guidance on reagents for detection of specific novel influenza A viruses.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Focus Groups as Used by the Food and Drug Administration'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Organ Procurement Organizations System (OPOS), System No. 09-70-0575.'' The Organ Procurement Organization (OPO) Certification Act of 2000 (Sec. 701 of Pub. L. 106-505) directs the Secretary of HHS to establish regulations that provide the statutory qualifications and requirements that an OPO must meet in order for organ procurement costs to be reimbursed under the Medicare and Medicaid programs. As part of the efficient administration of this program, CMS is charged with the responsibility to conduct investigations, analysis, and reporting of adverse events that are described as an untoward, undesirable, and unanticipated event that causes death or serious injury. At this time, individually-identifiable data is only requested from OPOs under two circumstances: (1) Due to the suspicion that an infectious disease has been transmitted to a recipient; and (2) when there has been a complaint alleged against an OPO. CMS regional office survey and certification staff would request individually-identifiable data to complete the investigation. Due to certain investigatory activities related to this system, CMS proposes to exempt this system from the notification, access, correction and amendment provisions of the Privacy Act of 1974. The purpose of this system is to collect and maintain individually identifiable information pertaining to complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the outcome of the investigation. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor, consultant or grantee; (2) assist another Federal or state agency in the enforcement of OPO regulations where sharing the information is necessary to complete the processing of a complaint, contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or enable such agency to administer a Federal health benefits program; (3) support constituent requests made to a Congressional representative; and (4) support litigation involving the agency. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations so that licensees who file financial reports with the Securities and Exchange Commission (SEC) or the Federal Energy Regulatory Commission (FERC), need not submit annual financial reports, including the certified financial statements, to the Commission. The Commission is also proposing to amend its regulations so that Independent Spent Fuel Storage Installation (ISFSI) licensees who file financial reports with the SEC or the FERC, need not submit annual financial reports, including the certified financial statements, to the Commission.

NMFS issues this final rule to implement recreational management measures for the 2006 summer flounder, scup, and black sea bass fisheries. The intent of these measures is to prevent overfishing of the summer flounder, scup, and black sea bass resources.

The Nuclear Regulatory Commission (NRC) is amending its regulations so that licensees who file financial reports with the Securities and Exchange Commission (SEC) or the Federal Energy Regulatory Commission (FERC), need not submit annual financial reports, including the certified financial statements, to the Commission. The Commission is also amending its regulations so that Independent Spent Fuel Storage Installation (ISFSI) licensees who file financial reports with the SEC or the FERC, need not submit annual financial reports, including the certified financial statements, to the Commission.

This action reconfigures Restricted Areas R-3007A, B, C, and D, and revokes Restricted Area R-3007E, Townsend, GA, by reducing the lateral size, increasing the vertical limits, and by increasing the time of designation of the restricted airspace by six hours per day. The FAA is taking this action to better accommodate Department of Defense (DOD) training requirements and to eliminate restricted airspace that is no longer needed by the military. Additionally, the name of the using agency for all R-3007 subareas is changed to reflect the current organizational title. This action also makes a minor correction to the latitude/longitude positions of two points in the descriptions of R-3007B and R-3007C.