Compliance Regulations and Guidance Affecting your Industry

The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue-based products (HCT/ Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization’s efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).

Effective Date: This rule is effective April 11, 2007

This guidance represents the Food and Drug Administration's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations

PHMSA is confirming the effective date of its direct final rule, published under Docket No. PHMSA– 2009–0238 (HM–224G) on October 15, 2009, to amend the Hazardous Materials Regulations by revising the quantity limitation from 25 kg ‘‘gross’’ to 25 kg ‘‘net’’ for packages of chemical oxygen generators transported aboard cargo aircraft only. The direct final rule stated that it would become effective on November 16, 2009 unless an adverse comment or notice of intent to file an adverse comment was received by November 16, 2009. PHMSA did not receive any adverse comments or notice of intent to file an adverse comment to its October 15, 2009 direct final rule

Effective Date: This rule is effective November 16, 2009

PHMSA is amending the Federal pipeline safety regulations to address human factors and other aspects of control room management for pipelines where controllers use supervisory control and data acquisition (SCADA) systems. Under the final rule, affected pipeline operators must define the roles and responsibilities of controllers and provide controllers with the necessary information, training, and processes to fulfill these responsibilities. Operators must also implement methods to prevent controller fatigue. The final rule further requires operators to manage SCADA alarms, assure control room considerations are taken into account when changing pipeline equipment or configurations, and review reportable incidents or accidents to determine whether control room actions contributed to the event. Hazardous liquid and gas pipelines are often monitored in a control room by controllers using computer-based equipment, such as a SCADA system, that records and displays operational information about the pipeline system, such as pressures, flow rates, and valve positions. Some SCADA systems are used by controllers to operate pipeline equipment, while, in other cases, controllers may dispatch other personnel to operate equipment in the field. These monitoring and control actions, whether via SCADA system commands or direction to field personnel, are a principal means of managing pipeline operation. This rule improves opportunities to reduce risk through more effective control of pipelines. It further requires the statutorily mandated human factors management. These regulations will enhance pipeline safety by coupling strengthened control room management with improved controller training and fatigue management

Effective Date: This rule is effective February 1, 2010

On January 31, 2007, PHMSA published a final rule that amended requirements in the Hazardous Materials Regulations applicable to the air transportation of compressed oxygen cylinders and oxygen generators. In response to appeals submitted by entities affected by the January 31 final rule, this final rule amends requirements adopted in the January 31, 2007 final rule and delays the effective date of these requirements from October 1, 2007 to October 1, 2008.

Effective Date: This rule is effective January 31, 2007

PHMSA is amending the Federal pipeline safety regulations to address human factors and other aspects of control room management for pipelines where controllers use supervisory control and data acquisition (SCADA) systems. Under the final rule, affected pipeline operators must define the roles and responsibilities of controllers and provide controllers with the necessary information, training, and processes to fulfill these responsibilities. Operators must also implement methods to prevent controller fatigue. The final rule further requires operators to manage SCADA alarms, assure control room considerations are taken into account when changing pipeline equipment or configurations, and review reportable incidents or accidents to determine whether control room actions contributed to the event. Hazardous liquid and gas pipelines are often monitored in a control room by controllers using computer-based equipment, such as a SCADA system, that records and displays operational information about the pipeline system, such as pressures, flow rates, and valve positions. Some SCADA systems are used by controllers to operate pipeline equipment, while, in other cases, controllers may dispatch other personnel to operate equipment in the field. These monitoring and control actions, whether via SCADA system commands or direction to field personnel, are a principal means of managing pipeline operation. This rule improves opportunities to reduce risk through more effective control of pipelines. It further requires the statutorily mandated human factors management. These regulations will enhance pipeline safety by coupling strengthened control room management with improved controller training and fatigue management

Effective Date: This rule is effective February 1, 2010

PHMSA is amending the Federal Pipeline Safety Regulations to require operators of gas distribution pipelines to develop and implement integrity management (IM) programs. The purpose of these programs is to enhance safety by identifying and reducing pipeline integrity risks. The IM programs required by this rule are similar to those required for gas transmission pipelines, but tailored to reflect the differences in and among distribution pipelines. Based on the required risk assessments and enhanced controls, the rule also allows for riskbased adjustment of prescribed intervals for leak detection surveys and other fixed-interval requirements in the agency’s existing regulations for gas distribution pipelines. To further minimize regulatory burdens, the rule establishes simpler requirements for master meter and small liquefied petroleum gas (LPG) operators, reflecting the relatively lower risk of these small pipelines. In accordance with Federal law, the rule also requires operators to install excess flow valves on new and replaced residential service lines, subject to feasibility criteria outlined in the rule. This final rule addresses statutory mandates and recommendations from the DOT’s Office of the Inspector General (OIG) and stakeholder groups

Effective Date: This rule is effective February 2, 2010

This direct final rule incorporates by reference the most recent editions of API Specification 5L ‘‘Specification for Line Pipe’’ and API 1104 ‘‘Welding of Pipelines and Related Facilities.’’ The purpose of this update is to enable pipeline operators to utilize current technology, materials, and practices to help maintain a high level of safety relative to their pipeline operations. PHMSA is not eliminating the use of the current referenced standards but simply allowing the additional use of these new standards. PHMSA may in the future propose to eliminate the incorporation of the existing referenced standards

Effective Date: This rule is effective April 14, 2009

This is a final rule to amend PBGC’s regulation on Annual Financial and Actuarial Information Reporting. The amendments implement the provisions of the Pension Protection Act of 2006, Public Law 109–280 (PPA 2006), which changed the standards for determining which persons are required to report under section 4010 (Authority to Require Certain Information) of the Employee Retirement Income Security Act of 1974 and made other changes to the reporting requirements. In addition to providing guidance on implementing the PPA 2006 changes, the final rule waives reporting in certain cases for controlled groups with aggregate plan underfunding of $15 million or less, modifies the standards for determining which plans are exempt from the actuarial information requirements, revises the actuarial information requirements to conform with other PPA 2006 changes, and provides other clarifications

Effective Date: This rule is effective April 15, 2009

The Food and Drug Administration (FDA) is confirming the effective date of March 27, 2009, for the direct final rule that appeared in the Federal Register of November 12, 2008 (73 FR 66750). The direct final rule amends the agency’s regulations to update the statutory citations regarding the new civil monetary penalties prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA), amends the regulations to include the new FDAAA penalties, and adjusts the preceding maximum civil penalty amounts for inflation as prescribed by the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). This document confirms the effective date of the direct final rule

This final rule adopts, with minor modifications, an interim final rule issued by PHMSA on March 28, 2008, conforming PHMSA’s administrative procedures with the Pipeline Inspection, Protection, Enforcement, and Safety Act of 2006 by establishing the procedures PHMSA will follow for issuing safety orders and handling requests for special permits, including emergency special permits. The rule also notifies operators about electronic docket information availability; updates addresses for filing reports, telephone numbers, and routing symbols; and clarifies the time period for processing requests for written interpretations of the regulations. This final rule makes minor amendments and technical corrections to the regulatory text in response to written public comments received after issuance of the interim final rule

Effective Date: This rule is effective February 17, 2009.

This final rule amends the design factor and design pressure limits for natural gas pipelines made from new Polyamide–11 (PA–11) thermoplastic pipe. Together, these two changes in the regulations allow pipeline operators to operate certain pipelines constructed of new PA–11 pipe at higher operating pressures than is currently allowed for other plastic pipe materials.

Effective Date: This rule is effective January 23, 2009

PHMSA is amending the pipeline safety regulations to prescribe safety requirements for the operation of certain gas transmission pipelines at pressures based on higher operating stress levels. The result is an increase of maximum allowable operating pressure (MAOP) over that currently allowed in the regulations. Improvements in pipeline technology assessment methodology, maintenance practices, and management processes over the past twenty-five years have significantly reduced the risk of failure in pipelines and necessitate updating the standards that govern the MAOP. This rule will generate significant public benefits by reducing the number and consequences of potential incidents and boosting the potential capacity and efficiency of pipeline infrastructure, while promoting rigorous life-cycle maintenance and investment in improved pipe technology.

Effective Date: This rule is effective  November 17, 2008

This final rule requires operators to use design and construction features in new and replaced gas transmission pipelines to reduce the risk of internal corrosion. The design and construction features required by this rule will reduce the risk of internal corrosion and related pipeline failures by reducing the potential for accumulation of liquids and facilitating operation and maintenance practices that address internal corrosion.

Effective Date: This rule is effective  May 23, 2007

PHMSA is amending a final rule published in the Federal Register on June 9, 2006, which updated the pipeline safety regulations to incorporate by reference all or parts of new editions of voluntary consensus technical standards to enable pipeline operators to utilize current technology, materials, and practices

Effective Date:This rule is effective  March 5, 2007

This final rule is part of the Department’s effort to fulfill its responsibilities under the Faith-Based and Community Initiative pursuant to Executive Orders 13279 and 13280. Under this rule, State agencies will collect and report information related to institutions and organizations that participate in specified Food and Nutrition Service (FNS) nutrition assistance programs. This information will be a new collection for the affected programs. It will enable FNS to identify the faith-based and community organizations participating in Federal nutrition assistance programs and determine the level of participation of faith-based and community organizations in the programs. It will not adversely impact the application or participation of any organization or institution currently participating in, or seeking to participate in, FNS nutrition assistance programs.

Under current regulations governing integrity management of gas transmission lines, if an operator uses direct assessment to evaluate corrosion risks, it must carry out the direct assessment according to PHMSA standards. In response to a statutory directive, this Final Rule prescribes similar standards operators must meet when they use direct assessment on certain other onshore gas, hazardous liquid, and carbon dioxide pipelines. PHMSA believes broader application of direct assessment standards will enhance public confidence in the use of direct assessment to assure pipeline safety

 Effective Date:This rule is effective November 25, 2005

The FDIC is amending its regulations requiring insured institutions to prepay their estimated quarterly risk-based assessments for the fourth quarter of 2009, and for all of 2010, 2011, and 2012. The prepaid assessment for these periods will be collected on December 30, 2009, along with each institution’s regular quarterly risk-based deposit insurance assessment for the third quarter of 2009. For purposes of estimating an institution’s assessments for the fourth quarter of 2009, and for all of 2010, 2011, and 2012, and calculating the amount that an institution will prepay on December 30, 2009, the institution’s assessment rate will be its total base assessment rate in effect on September 30, 2009.1 On September 29, 2009, the FDIC increased annual assessment rates uniformly by 3 basis points beginning in 2011.2 As a result, an institution’s total base assessment rate for purposes of estimating an institution’s assessment for 2011 and 2012 will be increased by an annualized 3 basis points beginning in 2011. Again for purposes of calculating the amount that an institution will prepay on December 30, 2009, an institution’s third quarter 2009 assessment base will be increased quarterly at a 5 percent annual growth rate through the end of 2012. The FDIC will begin to draw down an institution’s prepaid assessments on March 30, 2010, representing payment for the regular quarterly risk-based assessment for the fourth quarter of 2009

Effective Date: This rule is effective November 17,2009

To ensure an orderly phaseout of the Debt Guarantee Program (DGP), a component of the Temporary Liquidity Guarantee Program (TLGP), the FDIC is establishing a limited emergency guarantee facility. For most insured depository institutions and other entities participating in the DGP, the Debt Guarantee Program will conclude on October 31, 2009, with the FDIC’s guarantee expiring no later than December 31, 2012. To the extent that certain of those entities become unable to issue non-guaranteed debt to replace maturing senior unsecured debt because of market disruptions or other circumstances beyond their control, the emergency guarantee facility will be available on an application basis. In order to utilize the emergency guarantee facility, an entity must apply to, and receive prior approval from, the FDIC. If the application is approved, the FDIC will guarantee the applicant’s senior unsecured debt issued on or before April 30, 2010. Debt guaranteed under the emergency guarantee facility will be subject to an annualized assessment rate equal to a minimum of 300 basis points

Effective Date:This rule is effective October 23, 2009

The FDIC is adopting a final rule amending its deposit insurance regulations to: Reflect Congress’s extension, until December 31, 2013, of the temporary increase in the standard maximum deposit insurance amount (‘‘SMDIA’’) from $100,000 to $250,000; finalize the interim rule, with minor modifications, on revocable trust accounts; and finalize the interim rule on mortgage servicing accounts. The FDIC is also adopting technical, conforming amendments to its international banking regulations to substitute several existing references to ‘‘$100,000’’ with references to the SMDIA

Effective Date: This rule is effective October 19, 2009