October 25, 2007 – Federal Register Recent Federal Regulation Documents

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of eleven newly-designated individuals whose property and interests in property are blocked pursuant to Executive Order 13310 of July 28, 2003, ``Blocking Property of the Government of Burma and Prohibiting Certain Transactions.''

The Commissioner has determined (1) A 2.3 percent cost-of-living increase in Social Security benefits under title II of the Social Security Act (the Act), effective for December 2007; (2) An increase in the Federal Supplemental Security Income (SSI) monthly benefit amounts under title XVI of the Act for 2008 to $637 for an eligible individual, $956 for an eligible individual with an eligible spouse, and $319 for an essential person; (3) The student earned income exclusion to be $1,550 per month in 2008 but not more than $6,240 in all of 2008; (4) The dollar fee limit for services performed as a representative payee to be $35 per month ($68 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 2008; (5) The dollar limit on the administrative-cost assessment charged to attorneys representing claimants to be $79 in 2008; (6) The national average wage index for 2006 to be $38,651.41; (7) The Old-Age, Survivors, and Disability Insurance (OASDI) contribution and benefit base to be $102,000 for remuneration paid in 2008 and self-employment income earned in taxable years beginning in 2008; (8) The monthly exempt amounts under the Social Security retirement earnings test for taxable years ending in calendar year 2008 to be $1,130 and $3,010; (9) 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 2008 to be $711 and $4,288; (10) The dollar amounts (``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 2008 to be $909, $1,312, and $1,711; (11) The amount of taxable earnings a person must have to be credited with a quarter of coverage in 2008 to be $1,050; (12) The ``old-law'' contribution and benefit base to be $75,900 for 2008; (13) The monthly amount deemed to constitute substantial gainful activity for statutorily blind individuals in 2008 to be $1,570, and the corresponding amount for non-blind disabled persons to be $940; (14) The earnings threshold establishing a month as a part of a trial work period to be $670 for 2008; and (15) Coverage thresholds for 2008 to be $1,600 for domestic workers and $1,400 for election workers.

The Trade Policy Staff Committee (TPSC) is seeking the views of interested parties on the operation of the Caribbean Basin Economic Recovery Act (CBERA), as amended by the Caribbean Basin Trade Partnership Act (CBTPA) (19 U.S.C. 2701 et seq.). Section 212(f) of the CBERA, as amended, requires the President to submit a report to Congress regarding the operation of the CBERA and CBTPA (together commonly referred to as the Caribbean Basin Initiative, or CBI) on or before December 31, 2001, and every two years thereafter. The TPSC invites written comments concerning the operation of the CBI, including comments on the performance of each CBERA and CBTPA beneficiary country, as the case may be, under the criteria described in sections 212(b), 212(c), and 213(b)(5)(B) of the CBERA, as amended. This information will be used in the preparation of a report to the U.S. Congress on the operation of the program.

The Food and Drug Administration (FDA) is announcing the availability of draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this document were developed using the process described in that guidance.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation.'' This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI). This guidance defines severe DILI as injury that is fatal or requires liver transplantation. This guidance does not address the postmarketing evaluation of DILI.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of spinosad chewable tablets to kill fleas and for the prevention and treatment of flea infestations on dogs for 1 month.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled `` Guidance for Industry on Continuous Marketing Applications: PilotScientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act`` 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 amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for a revised human food safety warning for phenylbutazone paste, used in horses for relief of inflammatory conditions associated with the musculoskeletal system.

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of one newly-designated individual and one newly-designated entity whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, ``Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.''

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of three newly-designated individuals whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, ``Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.''

The National Oceanic and Atmospheric Administration publishes this notice to announce a 45-day public comment period for the draft report titled, U.S. Climate Change Science Program Synthesis and Assessment Product 4.7: ``Impacts of Climate Change and Variability on Transportation Systems and Infrastructure: Gulf Coast Study.'' This draft document is being released solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by NOAA. It does not represent and should not be construed to represent any Agency policy or determination. After consideration of comments received on the draft report, a revised version along with the comments received will be published on the CCSP web site.

The Department of Commerce (``the Department'') seeks public comment on its development of a methodology for determining whether targeted dumping is occurring in antidumping investigations. The Department seeks input on standards and tests that may be appropriate in a targeted dumping analysis.

On June 4, 2007, the Department of Commerce (the ``Department'') published its preliminary determination of sales at less than fair value (``LTFV'') in the antidumping investigation of coated free sheet paper (``CFS'') from the People's Republic of China (``PRC''). The period of investigation (``POI'') is April 1, 2006, through September 30, 2006. We invited interested parties to comment on our preliminary determination of sales at LTFV. Based on our analysis of the comments we received, we have made changes to our calculations for the mandatory respondents. The final dumping margins for this investigation are listed in the ``Final Determination Margins'' section below.

The Department of Commerce (the Department) is extending the time limit for the final results of the administrative review of the antidumping duty order on certain stainless steel butt-weld pipe fittings from Taiwan. The period of review is June 1, 2005, through May 31, 2006. This extension is made pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act).

We determine that imports of coated free sheet paper (``CFS paper'') are being, or are likely to be, sold in the United States at less than fair value (``LTFV''), as provided in section 735 of the Tariff Act of 1930, as amended (``the Act''). The estimated margins of sales at LTFV are shown in the ``Final Determination'' section of this notice.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995 (PRA), Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. Subject to the PRA, no person shall be subject to any penalty for failing to comply with a collection of information 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 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; 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.

The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. 24 CFR part 55 implements decision making procedures prescribed by E.O.11988 with which applicants must comply before HUD financial assistance can be approved for projects that are located within floodplains. Records of compliance must be kept.