October 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need to Know About Administrative Detention of Foods.'' This guidance provides information pertaining to FDA's authority to order the administrative detention of food for human or animal consumption under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA).

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

This document amends the U.S. Customs and Border Protection (CBP) regulations by adding provisions for the use of sampling methods in CBP audits and prior disclosure cases and for the offsetting of overpayments and over-declarations when an audit involves a calculation of lost duties, taxes, or fees or monetary penalties under 19 U.S.C. 1592. The sampling provision may be used by both CBP and private parties in certain circumstances. The offsetting provision is in accordance with CBP's authority under 19 U.S.C. 1509(b)(6).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Albert Cioffi, MD for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Cioffi was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Cioffi was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Cioffi failed to request a hearing. Dr. Cioffi's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

The Department of Commerce, 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.

The Department of Labor (DOL or Department) is committed to Environmental Justice (EJ). President Obama has renewed agencies' environmental justice planning by reinvigorating Executive Order 12898 (EO 12898), which tasked several Federal agencies with making environmental justice part of their mission. The agencies were directed to do so by identifying and addressing, as appropriate, the disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority and low-income populations. In August 2011, agencies listed in EO 12898 signed a Memorandum of Understanding (EJ MOU), which, among other things, commits agencies to develop a final Environmental Justice Strategy. The purpose of this notice is to invite public comment on how the Department of Labor can address environmental justice through its programs, policies, regulations or reporting requirements.

Under title II of the Social Security Act (Act), there will be a 3.6 percent cost-of-living increase in Social Security benefits effective December 2011. As a result of this increase, the following items will increase for 2012: (1) The maximum Federal Supplemental Security Income (SSI) monthly benefit amounts for 2012 under title XVI of the Act will be $698 for an eligible individual, $1,048 for an eligible individual with an eligible spouse, and $350 for an essential person; (2) The special benefit amount under title VIII of the Act for certain World War II veterans will be $523.50 for 2012; (3) The student earned income exclusion under title XVI of the Act will be $1,700 per month in 2012, but not more than $6,840 for all of 2012; (4) The dollar fee limit for services performed as a representative payee will be $38 per month ($75 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 2012; and (5) The dollar limit on the administrative-cost assessment charged to attorneys representing claimants will be $86 in 2012. The national average wage index for 2010 is $41,673.83. This index affects the following amounts: (1) The Old-Age, Survivors, and Disability Insurance (OASDI) contribution and benefit base will be $110,100 for remuneration paid in 2012 and self-employment income earned in taxable years beginning in 2012; (2) The monthly exempt amounts under the OASDI retirement earnings test for taxable years ending in calendar year 2012 will be $1,220, for years prior to the year in which a person attains his or her Normal Retirement Age (NRA) and $3,240, for the year in which a person attains his or her NRA; (3) The dollar amounts (``bend points'') used in the primary insurance amount (PIA) benefit formula for workers who become eligible for benefits, or who die before becoming eligible, in 2012 will be $767 and $4,624; (4) 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 2012 will be $980, $1,415, and $1,845; (5) The amount of taxable earnings a person must have to be credited with a quarter of coverage in 2012 will be $1,130; (6) The ``old-law'' contribution and benefit base under title II of the Act will be $81,900 for 2012; (7) The monthly amount deemed to constitute substantial gainful activity for statutorily blind individuals in 2012 will be $1,690, and the corresponding amount for non-blind disabled persons will be $1,010; (8) The earnings threshold establishing a month as a part of a trial work period will be $720 for 2012; and (9) Coverage thresholds for 2012 will be $1,800 for domestic workers and $1,500 for election officials and election workers.

This is an amendment of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-4019-DR), dated 08/31/2011. Incident: Hurricane Irene. Incident Period: 08/25/2011 through 09/01/2011. Effective Date: 10/17/2011. Physical Loan Application Deadline Date: 11/30/2011. EIDL Loan Application Deadline Date: 05/31/2012.

In accordance with 5 U.S.C. 4314(c)(4), the National Telecommunications and Information Administration (NTIA), Department of Commerce (DOC), announce the appointment of those individuals who have been selected to serve as members of NTIA's Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and rating of Senior Executive Service (SES) members and (2) making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES members. The appointment of these members to the Performance Review Board will be for a period of twenty- four (24) months.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD would require repetitive detailed inspections for discrepancies of the horizontal stabilizer ballscrew assembly; repetitive lubrication of the horizontal stabilizer trim control system; repetitive measurements for discrepancies of the ballscrew to ballnut freeplay; and corrective actions if necessary. This proposed AD was prompted by a report of extensive corrosion of the ballscrew of the drive mechanism of the horizontal stabilizer trim actuator. We are proposing this AD to prevent undetected failure of the primary and secondary load paths for the ballscrew in the horizontal stabilizer, which could lead to loss of control of the horizontal stabilizer and consequent loss of control of the airplane.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Pennsylvania (FEMA-4030-DR), dated 10/07/2011. Incident: Tropical Storm Lee. Incident Period: 09/03/2011 through 10/15/2011. Effective Date: 10/15/2011. Physical Loan Application Deadline Date: 12/06/2011. Economic Injury (EIDL) Loan Application Deadline Date: 07/09/2012.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Texas (FEMA4029DR), dated 09/21/2011. Incident: Wildfires. Incident Period: 08/30/2011 and continuing. Effective Date: 10/13/2011. Physical Loan Application Deadline Date: 11/21/2011. Economic Injury (EIDL) Loan Application Deadline Date: 06/21/2012.