2008 – Federal Register Recent Federal Regulation Documents

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 Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2008.

We, the Fish and Wildlife Service (Service), amend the regulations at 50 CFR part 17, which implement the Endangered Species Act, as amended (ESA), to create a final special rule under authority of section 4(d) of the ESA that provides measures that are necessary and advisable to provide for the conservation of the polar bear (Ursus maritimus). The special rule, in most instances, adopts the existing conservation regulatory requirements under the Marine Mammal Protection Act of 1972, as amended (MMPA), and the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) as the appropriate regulatory provisions for this threatened species. Nonetheless, if an activity is not authorized or exempted under the MMPA or CITES and would result in an act that would be otherwise prohibited under the general prohibitions under the ESA for threatened species (50 CFR 17.31), then the prohibitions at 50 CFR 17.31 apply, and we would require authorization under 50 CFR 17.32. In addition, this special rule provides that any incidental take of polar bears that results from activities that occur outside of the current range of the species is not a prohibited act under the ESA. This special rule does not affect any existing requirements under the MMPA, including incidental take restrictions, or CITES, regardless of whether the activity occurs inside or outside the current range of the polar bear. Further, nothing in this special rule affects the consultation requirements under section 7 of the ESA.

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 Federal Communications Commission, as part of its continuing effort to reduce paperwork burden, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

We invite the public to comment on the following applications to conduct certain activities with endangered species.

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 postmarketing adverse drug experience reporting and recordkeeping requirements.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill four upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).

This rule provides a partial exemption to the minimum grade requirements under the marketing order for tomatoes grown in Florida (order). The order regulates the handling of tomatoes grown in Florida and is administered locally by the Florida Tomato Committee (Committee). Absent an exemption, Florida tomatoes covered by the order must meet at least a U.S. No. 2 grade before they can be shipped and sold outside the regulated area. This rule exempts Vintage Ripes\TM\ tomatoes (Vintage Ripes\TM\) from the shape requirements associated with the U.S. No. 2 grade. This change increases the volume of Vintage Ripes\TM\ that will meet the order requirements, and will help increase shipments and availability of these tomatoes.

This notice announces that the Commodity Credit Corporation (CCC) has completed a Final Programmatic Environmental Assessment (PEA) and is issuing a Finding of No Significant Impact (FONSI) with respect to the implementation of changes to the Conservation Reserve Program (CRP) and changes to the Farmable Wetlands Program (FWP) authorized by the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill). FWP operates as part of CRP.

The ONMS is seeking applicants for the following three vacant seats on the Olympic Coast National Marine Sanctuary Advisory Council (council): Research, Marine Business/Ports/Industry, and Conservation/ Environmental. Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; philosophy regarding the protection and management of marine resources; and possibly the length of residence in the area affected by the sanctuary. Applicants who are chosen as members and alternates should expect to serve 3-year terms, pursuant to the council's Charter.

The ONMS is seeking applicants for the following vacant seats on the Stellwagen Bank National Marine Sanctuary Advisory Council (council): Business and Industry (Alternate). Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; philosophy regarding the protection and management of marine resources; and possibly the length of residence in the area affected by the sanctuary. Applicants who are chosen as members should expect to serve two-to-three-year terms, pursuant to the council's Charter.

In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR Part 107, Subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the ``Nature of Application'' portion of the table below as follows: 1Motor vehicle, 2Rail freight, 3Cargo vessel, 4Cargo aircraft only, 5Passenger-carrying aircraft.

The Coast Guard published a document in the Federal Register on October 31, 2008 (73 FR 65156), revising rules relating to standards for marine equipment. That document provided incorrect amendatory instruction for 46 CFR 56.30-10. This document corrects the final regulation by revising the amendatory instruction.

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 Bureau of the Public Debt within the Department of the Treasury is soliciting comments concerning the Application By Voluntary Guardian of Incapacitated Owner of United States Savings Bonds/Notes.

FMCSA amends the New Entrant Safety Assurance Program regulations to raise the standard of compliance for passing the new entrant safety audit. The Agency identifies 16 regulations that are essential elements of basic safety management controls necessary to operate in interstate commerce and makes a carrier's failure to comply with any one of the 16 regulations an automatic failure of the safety audit. Additionally, if certain violations are discovered during a roadside inspection, the new entrant now will be subject to expedited actions to correct these deficiencies. The Agency now will also check compliance with the Americans with Disabilities Act and certain household goods-related requirements in the new entrant safety audit, if they apply to the new entrant's operation. Failure to comply with either of these requirements will not affect the outcome of the safety audit; however, the Agency will take appropriate actions to improve compliance. FMCSA clarifies changes to some of the existing new entrant regulations and establishes a separate new entrant application procedure and safety oversight program for non-North America-domiciled motor carriers. Finally, the Agency has enhanced the quality and availability of its educational and technical assistance (ETA) materials to ensure applicants are knowledgeable about applicable Federal motor carrier safety standards. Because the Agency believes Form MCS-150ASafety Certification for Application for USDOT Number is not an effective instrument for establishing knowledgeability, it is eliminating that form. FMCSA believes this rule will improve the Agency's ability to identify at-risk new entrant carriers and ensure deficiencies in basic safety management controls are corrected before the new entrant is granted permanent registration. These changes do not impose additional regulatory requirements on any new entrant carrier because these carriers are already required to comply with all applicable rules.

We, the U.S. Fish and Wildlife Service (Service), propose to designate critical habitat for the southwest Alaska Distinct Population Segment (DPS) of the northern sea otter (Enhydra lutris kenyoni) under the Endangered Species Act of 1973, as amended (Act). In total, approximately 15,225 square kilometers (km\2\) (5,879 square miles (mi\2\)) fall within the boundaries of the proposed critical habitat designation. The proposed critical habitat is located in Alaska.

NMFS announces receipt of a petition for rulemaking under the Administrative Procedure Act. Center for Biological Diversity and Turtle Island Restoration Network, non-governmental organizations, have petitioned the U.S. Department of Commerce and other relevant Departments to initiate rulemaking to ban importation of commercial fish or products from fish that have been caught with commercial fishing technology that results in incidental mortality or serious injury of marine mammals in excess of United States standards.

The Environmental Protection Agency (EPA) established the Clean Air Act Advisory Committee (CAAAC) on November 19, 1990, to provide independent advice and counsel to EPA on policy issues associated with implementation of the Clean Air Act of 1990. The Committee advises on economic, environmental, technical, scientific, and enforcement policy issues.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) to request an extension without change of a currently approved collection of information: 3220-0082, Medicare. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collection of information to determine (1) the practical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if RRB and OIRA receive them within 30 days of publication date. Under Section 7(d) of the Railroad Retirement Act (RRA), the Railroad Retirement Board (RRB) administers the Medicare program for persons covered by the railroad retirement system. The RRB uses Form AA-6, Employee Application for Medicare; Form AA-7, Spouse/Divorced Spouse Application For Medicare; and Form AA-8, Widow/Widower Application for Medicare; to obtain the information needed to determine whether individuals who have not yet filed for benefits under the RRA are qualified for Medicare payments provided under Title XVIII of the Social Security Act. Further, in order for the RRB to determine if a qualified railroad retirement beneficiary who is claiming supplementary medical insurance coverage under Medicare is entitled to a Special Enrollment Period (SEP) and/or premium surcharge relief because of coverage under an Employer Group Health Plan (EGHP), it needs to obtain information regarding the claimant's EGHP coverage, if any. The RRB uses Form RL- 311-F, Evidence of Coverage Under an Employer Group Health Plan, to obtain the basic information needed by the RRB to establish EGHP coverage for a qualified railroad retirement beneficiary. Completion of the forms is required to obtain a benefit. One response is requested of each respondent. Previous Requests for Comments: The RRB has already published the initial 60-day notice (73 FR 34965 and 34966 on June 19, 2008) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) to request an extension without change of a currently approved collection of information: 3220-0140, Employee's Certification. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collection of information to determine (1) the practical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if RRB and OIRA receive them within 30 days of publication date. Section 2 of the Railroad Retirement Act (RRA) provides for the payment of an annuity to the spouse or divorced spouse of a retired railroad employee. For the spouse or divorced spouse to qualify for an annuity, the RRB must determine if the employee's current marriage to the applicant is valid. The requirements for obtaining documentary evidence to determine valid marital relationships are prescribed in 20 CFR 219.30 through 219.35. Section 2(e) of the RRA requires that an employee must relinquish all rights to any railroad employer service before a spouse annuity can be paid. The RRB uses Form G-346 to obtain the information needed to determine whether the employee's current marriage is valid. Form G-346 is completed by the retired employee who is the husband or wife of the applicant for a spouse annuity. Completion is required to obtain a benefit. One response is requested of each respondent. The RRB proposes no change to Form G-346. The RRB estimates the completion time for Form G-346 at five minutes per response. Previous Requests for Comments: The RRB has already published the initial 60-day notice (73 FR 51535 and 51536 on September 3, 2008) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.