Compliance Regulations and Guidance Affecting your Industry

The FMCSA amends the Federal Motor Carrier Safety Regulations (FMCSRs) to require that motor carriers operating commercial motor vehicles (CMVs), designed or used to transport between 9 and 15 passengers (including the driver), in interstate commerce for direct compensation comply with the safety regulations regardless of the distance traveled. Specifically, this rule makes certain FMCSRs applicable to the operation of such vehicles when they are operated within a 75 air-mile radius (86.3 statute miles or 138.9 kilometers) from the driver’s normal work-reporting location. Motor carriers, drivers, and the vehicles operated by them will be subject to the same safety requirements imposed upon such vehicles when they are operated beyond a 75-air-mile radius. This action is required by the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA–LU).

Effective Date: This rule is effective May 3, 2010. Compliance: Motor carriers must be in compliance with this rule no later than June 1, 2010.

The U.S. Department of Energy (DOE) is adopting energy conservation standards for small electric motors. DOE has determined that these standards will result in significant conservation of energy, and are technologically feasible and economically justified.

Effective Date: The effective date of this rule is April 8, 2010. The standards established in today’s final rule will be applicable starting March 9, 2015.

The U.S. Department of Energy (DOE) is establishing metal halide lamp ballast test procedures in today’s final rule by which manufacturers will demonstrate compliance with the metal halide lamp fixture energy conservation standards mandated by the Energy Policy and Conservation Act (EPCA), as amended. These test procedures are based primarily on and incorporate by reference provisions of American  National Standards Institute (ANSI) Standard C82.6–2005, ‘‘Ballasts for High-Intensity Discharge Lamps— Methods of Measurement.’’ As further required by EPCA, DOE is establishing a test method for measuring standby mode power consumption and explaining why off mode power consumption does not apply to metal halide lamp ballasts. The test procedures’ standby mode provisions are based on the International Electrotechnical Commission (IEC) Standard 62301, ‘‘Household electrical appliances—Measurement of standby power.’’ This rule also adopts a number of definitions for key terms.

Effective Date: These test procedures are effective on April 8, 2010. The incorporation by reference of a certain  publication listed in this rule is approved by the Director of the Federal Register as of April 8, 2010.

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

The Secretary of Health and Human Services is adopting rules to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005, Pub. L. 109–41, 42 U.S.C. 299b– 21—b–26 (Patient Safety Act). The final rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The final rule outlines the requirements that entities must meet to become PSOs and the processes by which the Secretary will review and accept certifications and list PSOs. It also describes the privilege and confidentiality protections for the information that is assembled and developed by providers and PSOs, the exceptions to these privilege and confidentiality protections, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.

Effective Date: The final rule is effective on January 19, 2009.

The California Fair Employment and Housing Commission has recently promulgated new regulations interpreting AB 1825.The Fair Employment and Housing Commission enforces California civil rights laws regarding discrimination in employment, housing, and public accommodations; pregnancy disability leave; family and medical leave; and hate violence.  

Effective Date: Approved by the Office of Administrative Law on July 18, 2007. To become Effective August 17, 2007.

The Secretary amends our regulations implementing the Family Educational Rights and Privacy Act (FERPA), which is section 444 of the General Education Provisions Act. These amendments are needed to implement a provision of the USA Patriot Act and the Campus Sex Crimes Prevention Act, which added new exceptions permitting the disclosure of personally identifiable information from education records without consent. The amendments also implement two U.S. Supreme Court decisions interpreting FERPA, and make necessary changes identified as a result of the Department’s experience administering FERPA and the current regulations. These changes clarify permissible disclosures to parents of eligible students and conditions that apply to disclosures in health and safety emergencies; clarify permissible disclosures of student identifiers as directory information; allow disclosures to contractors and other outside parties in connection with the outsourcing of institutional services and functions; revise the definitions of  ttendance, disclosure, education records, personally identifiable information, and other key terms; clarify permissible redisclosures by State and Federal officials; and update investigation and  enforcement provisions.
 

Effective Date: These regulations are effective January 8, 2009.

There have been no internationally accepted objectives or recommendations on the design and conduct of nonclinical studies to support the development of anticancer pharmaceuticals in patients with advanced disease and limited therapeutic options. Hence FDA recently produced a draft guidance whose aim is to establish an internationally accepted objectives /recommendations on how to design and conduct  nonclinical studies for development of anticancer pharmaceuticals in patients with advanced disease and limited therapeutic options.

The purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. This guideline aims to facilitate and accelerate the development of anticancer pharmaceuticals and to protect patients from unnecessary adverse effects, while avoiding unnecessary use of animals and other resources.

This guideline provides information for pharmaceuticals that are only intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived pharmaceuticals. This guideline describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals and references other guidance as appropriate.

 

This rulemaking transfers the FAA’s rules governing civil aviation security to TSA. This rulemaking also amends those rules to enhance security as required by recent legislation. This rulemaking also requires additional qualifications, training, and testing of individuals who screen persons and property that are carried in passenger aircraft. It is intended to improve the quality of screening conducted by aircraft operators and foreign air carriers. This rule is being adopted to improve the qualifications of individuals performing screening, and thereby to improve the level of security in air transportation. This will help ensure a smooth transition of aviation security from the FAA to TSA, and will avoid disruptions in air transportation due to any shortage of qualified screeners.

Effective Date: This rule is effective February 17, 2002. The incorporation by reference of certain publications in the rule is approved by the Director of the Federal Register as of February 17, 2002. Submit comments by March 25, 2002.

This rule implements the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996. The Commission is adopting a rule adjusting for inflation the maximum amount of civil monetary penalties under the Securities Act of 1933, the Securities Exchange Act of 1934, the Investment Company Act of 1940, the Investment Advisers Act of 1940, and certain penalties under the Sarbanes-Oxley Act of 2002.

Effective Date: This rule is effective March 3, 2009.

We are adopting rule and form amendments that allow applicants for EDGAR access codes using Form ID to submit their authenticating documents by attaching them to their online Form ID applications in Portable Document Format (PDF) as an alternative to submitting the documents by fax.

Effective Date: This rule is effective March 16, 2009

The Securities and Exchange Commission (“Commission”) is finalizing amendments to Regulation SHO under the Securities Exchange Act of 1934 (“Exchange Act”) by making permanent amendments contained in Interim Final Temporary Rule 204T (“temporary Rule 204T”) of Regulation SHO, with some modifications to address commenters’ concerns. These amendments are intended to help further our goal of reducing fails to deliver by maintaining the reductions in fails to deliver achieved by the adoption of temporary Rule 204T, as well as other actions taken by the Commission. In addition, these amendments are intended to help further our goal of addressing abusive “naked” short selling in all equity securities. These goals will be furthered by requiring that, subject to certain limited exceptions, if a participant of a registered clearing agency has a fail to deliver position at a registered clearing agency it must immediately purchase or borrow securities to close out the fail to deliver position by no later than the beginning of regular trading hours on the settlement day following the day the participant incurred the fail to deliver position. Failure to comply with the close-out requirement of this final rule is a violation of the rule. In addition, a participant that does not comply with this closeout requirement, and any broker-dealer from which it receives trades for clearance and settlement, will not be able to short sell the security either for itself or for the account of another, unless it has previously arranged to borrow or borrowed the security, until the fail to deliver position is closed out.

Effective Date: This rule is effective July 31, 2009

The Securities and Exchange Commission (“Commission”) is adopting amendments to certain of its rules and forms to remove references to securities credit ratings. The Commission is eliminating certain references to credit ratings issued by nationally recognized statistical rating organizations (“NRSROs”) in rules and forms under the Securities Exchange Act of 1934 related to the regulation of self-regulatory organizations and alternative trading systems, and in rules under the Investment Company Act of 1940 that affect an investment company’s ability to purchase refunded securities and securities in underwritings in which an affiliate is participating. The Commission believes that the references to credit ratings in these rules and forms are no longer warranted as serving their intended purposes. The amendments are designed to address concerns that references to NRSRO ratings in Commission rules may have contributed to an undue reliance on those ratings by market participants. In a companion release, the Commission is re-opening the comment period for certain other proposed rule and form amendments that would eliminate additional references to NRSRO ratings.

Effective Date: This rule is effective Nivember 12, 2009

We are amending temporary rules that require companies that are non-accelerated filers to include in their annual reports, pursuant to rules implementing Section 404(b) of the Sarbanes-Oxley Act of 2002, an attestation report of their independent auditor on internal control over financial reporting for fiscal years ending on or after December 15, 2009. The amendments will extend the compliance date for filing attestation reports, so that a non-accelerated filer will be required to file the auditor’s attestation report on internal control over financial reporting when it files an annual report for a fiscal year ending on or after June 15, 2010.

Effective Date: This rule is effective December 18, 2009

We are amending temporary rules that require companies that are non-accelerated filers to include in their annual reports, pursuant to rules implementing Section 404(b) of the Sarbanes-Oxley Act of 2002, an attestation report of their independent auditor on internal control over financial reporting for fiscal years ending on or after December 15, 2009. The amendments will extend the compliance date for filing attestation reports, so that a non-accelerated filer will be required to file the auditor’s attestation report on internal control over financial reporting when it files an annual report for a fiscal year ending on or after June 15, 2010.

Effective Date: October 30, 2009. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 30, 2009.

The Securities and Exchange Commission is extending the compliance date for Regulation S-AM (74 FR 40398 (Aug. 11, 2009)), which limits a person’s use of certain information received from an affiliate to solicit a consumer for marketing purposes unless the consumer has been given notice and a reasonable opportunity and a reasonable and simple method to opt out of such solicitations.

Effective Date: The effective date for Regulation S-AM (17 CFR 248.101 through 248.128) remains September 10, 2009. The compliance date for Regulation S-AM is extended from January 1, 2010 to June 1, 2010.

The Commission is adopting rule amendments that impose additional disclosure and conflict of interest requirements on nationally recognized statistical rating organizations (“NRSROs”) in order to address concerns about the integrity of the credit rating procedures and methodologies at NRSROs.

Effective Date: This rule is effective 2 February, 2010

The Commission is adopting an amendment to Rule 312 of Regulation S-T to extend its application for one year. Rule 312 provides a temporary filing accommodation for filings with respect to asset-backed securities that allows static pool information required to be disclosed in a prospectus to be provided on an Internet Web site under certain conditions. Under the rule, such information is deemed to be included in the prospectus included in the registration statement for the asset-backed securities. As a result of the extension, the rule will apply to filings with respect to asset-backed securities filed on or before December 31, 2010.

Effective Date: This amendment is effective December 31, 2009

The Securities and Exchange Commission is adopting as final Rule 206(3)-3T under the Investment Advisers Act of 1940, the interim final temporary rule that establishes an alternative means for investment advisers who are registered with the Commission as broker-dealers to meet the requirements of Section 206(3) of the Investment Advisers Act when they act in a principal capacity in transactions with certain of their advisory clients. As adopted, the only change to the rule is the expiration date. Rule 206(3)-3T will sunset on December 31, 2010.

Effective Date: December 30, 2009, except 17 CFR 275.206(3)-3T will expire and no longer be effective on December 31, 2010

The Securities and Exchange Commission is adopting amendments to the custody and recordkeeping rules under the Investment Advisers Act of 1940 and related forms. The amendments are designed to provide additional safeguards under the Advisers Act when a registered adviser has custody of client funds or securities by requiring such an adviser, among other things: to undergo an annual surprise examination by an independent public accountant to verify client assets; to have the qualified custodian maintaining client funds and securities send account statements directly to the advisory clients; and unless client assets are maintained by an independent custodian (i.e., a custodian that is not the adviser itself or a related person), to obtain, or receive from a related person, a report of the internal controls relating to the custody of those assets from an independent public accountant that is registered with and subject to regular inspection by the Public Company Accounting Oversight Board. Finally, the amended custody rule and forms will provide the Commission and the public with better information about the custodial practices of registered investment advisers.

Effective Date: This rule will effect March 12, 2010