November 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

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 information collection contained in regulations governing the use of radioactive drugs for basic informational research (21 CFR 361.1).

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 information collection requirements for FDA regulations related to the exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile (SNS).

Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 110-343) the Idaho Panhandle Resource Advisory Committee will meet Friday, December 3, 2010, at 9 a.m. in Coeur d'Alene, Idaho for a business meeting. The business meeting is open to the public.

In accordance with the National Environmental Policy Act of 1969 (NEPA) and the FRA's Procedures for Considering Environmental Impacts (FRA Environmental Procedures) (64 FR 28545 (May 26, 1999)), the FRA and the Washington State Department of Transportation (WSDOT) prepared a Tier-1 Environmental Assessment (Tier-1 EA) that evaluates the impacts of a corridor improvements program to the Washington State portion of the Pacific Northwest Rail Corridor (PNWRC Program). This notice advises the public that FRA finds that the corridor improvement program will not have a significant impact on the quality of the human or natural environment and has issued a Finding of No Significant Impact (FONSI) supporting that determination. Copies of both the Tier-1 EA and FONSI are available on FRA's Web site at https://www.fra.dot.gov/ rpd/freight/3011.shtml.

Under title II of the Social Security Act (Act), there will be no cost-of-living increase in Social Security benefits effective for December 2010. As a result, the following items will remain at their 2010 levels: (1) The maximum Federal Supplemental Security Income (SSI) monthly benefit amounts for 2011, under title XVI of the Act, will remain $674 for an eligible individual, $1,011 for an eligible individual with an eligible spouse, and $338 for an essential person; (2) The special benefit amount under title VIII of the Act for certain World War II veterans will remain $505.50 in 2011; (3) The student earned income exclusion under title XVI of the Act will remain $1,640 per month in 2011, but not more than $6,600 in all of 2011; (4) The dollar fee limit for services performed as a representative payee will remain $37 per month ($72 per month in the case of a beneficiary who is disabled and has an alcoholism or drug addiction condition that leaves him or her incapable of managing benefits) in 2011; (5) The dollar limit on the administrative-cost assessment charged to attorneys representing claimants will remain $83 in 2011; (6) The Old-Age, Survivors, and Disability Insurance (OASDI) contribution and benefit base will remain $106,800 for remuneration paid in 2011 and self-employment income earned in taxable years beginning in 2011; (7) The monthly exempt amounts under the Social Security retirement earnings test for taxable years ending in calendar year 2011 will remain $1,180 and $3,140; (8) The ``old-law'' contribution and benefit base under title II of the Act will remain $79,200 for 2011; and (9) The monthly amount deemed to constitute substantial gainful activity for statutorily blind individuals in 2011 will remain $1,640. The national average wage index for 2009 is $40,711.61. This index affects the following items: (1) The dollar amounts (``bend points'') used in the primary insurance amount benefit formula for workers who become eligible for benefits, or who die before becoming eligible, in 2011 will be $749 and $4,517; (2) The bend points used in the formula for computing maximum family benefits for workers who become eligible for benefits, or who die before becoming eligible, in 2011 will be $957, $1,382, and $1,803; (3) The amount of taxable earnings a person must have to be credited with a quarter of coverage in 2011 will be $1,120; (4) The monthly amount deemed to constitute substantial gainful activity for non-blind disabled persons will be $1,000 in 2011; (5) The earnings threshold establishing a month as a part of a trial work period will be $720 for 2011; and (6) Coverage thresholds for 2011 will be $1,700 for domestic workers and $1,500 for election officials and election workers.

In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection abstracted below will be submitted to the Office of Management and Budget (OMB) for review and approval. The nature of the information collection is described as well as its expected burden. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on August 26, 2010. No comments were received.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2010 Harley Davidson FL Series Motorcycles 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 (1) they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards, and (2) they are capable of being readily altered to conform to the standards.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on October 25, 2010, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Thomson Licensing SAS of France and Thomson Licensing LLC of Princeton, New Jersey. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain liquid crystal display devices, including monitors, televisions, and modules, and components thereof by reason of infringement of certain claims of U.S. Patent No. 5,978,063 (``the `063 patent''); U.S. Patent No. 5,621,556 (``the `556 patent''); and U.S. Patent No. 5,375,006 (``the `006 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist orders.

As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to comment on the following information collection. 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 shall 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; (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; and (e) ways to further reduce the information collection burden for small business concerns with fewer than 25 employees. The FCC 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. Dates: Written Paperwork Reduction Act (PRA) comments should be submitted on or before December 30, 2010. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible. Addresses: Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202-395-5167 or the Internet at Nicholas_A._Fraser@omb.eop.gov; and to the Federal Communications Commission's PRA mailbox (e-mail address: PRA@fcc.gov). Include in the e-mail the OMB control number of the collection as shown in the SUPPLEMENTARY INFORMATION section below, or if there is no OMB control number, include the Title as shown in the SUPPLEMENTARY INFORMATION section. If you are unable to submit your comments by email, contact the person listed below to make alternate arrangements. For Further Information Contact: For additional information, contact Judith B. Herman at 202-418-0214 or via the Internet at Judith- b.herman@fcc.gov. Supplementary Information: OMB Control Number: 3060-1092. Title: Interim Procedures for Filing Applications Seeking Approval for Designated Entity Reportable Eligibility Events and Annual Reports. Form Nos.: FCC Form 609-T and 611-T. Type of Review: Extension of a currently approved collection. Respondents: Business or other for-profit, not-for-profit institutions, and state, local or tribal government. Number of Respondents: 1,100 respondents; 2,750 responses. Estimated Time per Response: FCC Form 609-T is estimated at 4 hours per response; FCC Form 611-T is estimated at 6 hours per response. Frequency of Response: Annual and on occasion reporting requirement and third party disclosure requirement. Obligation To Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 4(i), 308(b), 309(j)(3) and 309(j)(4). Total Annual Burden: 7,288 hours. Total Annual Cost: $1,494,625. Privacy Act Impact Assessment: N/A. Nature and Extent of Confidentiality: Some respondents may assert that some data and/or agreements that they are filing in response to these information collection requirements include confidential information or trade secrets. The Commission has long established procedures for accepting confidential and market-sensitive documents and information via the Commission's Universal Licensing System (ULS). These long standing procedures will be followed to ensure that no confidential materials or trade secrets are disclosed. Most of the information collected will be made available for public inspection. Applicants may seek confidential treatment pursuant to 47 CFR 0.459 of the Commission's rules governing requests to withhold from public inspection information submitted to the Commission. The ULS allows for information to be filed confidentially. Confidentially filed materials will only be accessible to Commission employees who have been issued passwords. Needs and Uses: The Commission will submit this expiring information collection (IC) to the OMB during this comment period. The Commission is reporting no change in its burden hour or annual cost estimates. The Commission is seeking OMB approval for an extension (there are no change to the reporting requirements). FCC Form 609-T is used by Designated Entities (DEs) to request prior Commission approval pursuant to Section 1.2114 of the Commission's rules for any reportable eligibility event. The data collected on the form is used by the FCC to determine whether the public interest would be served by the approval of the reportable eligibility event. FCC Form 611-T is used by DE licensees to file an annual report, pursuant to section 1.2110(n) of the Commission's rules, related to eligibility for designated entity benefits. The information collected will be used to ensure that only legitimate small businesses reap the benefits of the Commission's designated entity program. Further, this information will assist the Commission in preventing companies from circumventing the objectives of the designated entity eligibility rules by allowing us to review: (1) The FCC Form 609-T applications seeking approval for ``reportable eligibility events'' and (2) the FCC Form 611-T annual reports to ensure that licensees receiving designated entity benefits are in compliance with the Commission's policies and rules.

In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) Communications Security, Reliability, and Interoperability Council (CSRIC) will hold its fourth meeting on December 13, 2010, at 9 a.m. in the Commission Meeting Room of the Federal Communications Commission, Room TW-C305, 445 12th Street, SW., Washington, DC 20554.

We, the U.S. Fish and Wildlife Service (Service), announce the availability of our final comprehensive conservation plan (CCP) and finding of no significant impact (FONSI) for the environmental assessment (EA) for the Laguna Atascosa National Wildlife Refuge (NWR). In this final CCP, we describe how we will manage this refuge for the next 15 years.

We, the U.S. Fish and Wildlife Service (Service), announce the availability of our final comprehensive conservation plan (CCP) and finding of no significant impact (FONSI) for the environmental assessment (EA) for the Tishomingo National Wildlife Refuge (NWR). In this final CCP, we describe how we will manage this Refuge for the next 15 years.

The Department of Labor (DOL) hereby announces the submission of the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, ``Job Corps Enrollee Allotment Determination,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

The Department of Labor (DOL) hereby announces the submission of the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, ``Nonmonetary Determination Activity Report,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

We (U.S. Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This information collection is scheduled to expire on November 30, 2010. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.

In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The Meeting will be held for the purpose of soliciting from the scientific community and other persons scientific and technical information relevant to program planning.

The U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its regulations to make miscellaneous administrative changes, including an update of the list of Agreement and Non-Agreement States, the merging of the Region II materials program with that of Region I, the correction of office titles associated with the Office of Nuclear Material Safety and Safeguards and the Office of Federal and State Materials and Environmental Management Programs, the inclusion of references to new Executive Order (E.O.) 13526, and other edits, corrections, and conforming changes. This document is necessary to inform the public of these changes to the NRC's regulations.

In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection requirements associated with the Commission's rules and FCC Forms 301, 314, 315, 316 and 340. These rules and form changes were approved on May 27, 2010 and June 4, 2010 and the compliance date will be November 30, 2010.

The Department published in the Federal Register of October 24, 2007 a final regulation (the qualified default investment alternative regulation) providing relief from certain fiduciary responsibilities for fiduciaries of participant-directed individual account plans who, in the absence of directions from a participant, invest the participant's account in a qualified default investment alternative. On October 20, 2010, the Department published a final regulation that requires the disclosure of certain plan and investment- related information, including fee and expense information, to participants and beneficiaries in participant-directed individual account plans (the participant-level disclosure regulation). This document contains proposed amendments to the qualified default investment alternative regulation to provide more specificity as to the information that must be disclosed in the required notice to participants and beneficiaries concerning investments in qualified default investment alternatives, including target date or similar investments. This document also contains a proposed amendment to the participant-level disclosure regulation that would require the disclosure of the same information concerning target date or similar investments to all participants and beneficiaries in participant- directed individual account plans.