Compliance Regulations and Guidance Affecting your Industry

The Commission is adopting amendments to the proxy rules under the Securities Exchange Act of 1934 to set forth certain requirements for U.S. registrants subject to Section 111(e) of the Emergency Economic Stabilization Act of 2008. Section 111(e) of the Emergency Economic Stabilization Act of 2008 requires companies that have received financial assistance under the Troubled Asset Relief Program (“TARP”) to permit a separate shareholder advisory vote to approve the compensation of executives, as disclosed pursuant to the compensation disclosure rules of the Commission, during the period in which any obligation arising from financial assistance provided under the TARP remains outstanding. The amendments are intended to help implement this requirement by specifying and clarifying it in the context of the federal proxy rules.

Effective Date: This rule is effective 18 february, 2010

The Securities and Exchange Commission (“Commission”) is amending its rules to delegate authority to the Director of the Division of Enforcement (“Division”) to submit witness immunity order requests to the Department of Justice for witnesses who have provided or have the potential to provide substantial assistance in the Commission’s investigations and related enforcement actions. This delegation is intended to conserve Commission resources, enhance the Division’s ability to detect violations of the federal securities laws, increase the effectiveness and efficiency of the Division’s investigations, and improve the success of the Commission’s enforcement actions.

Effective Date: This rule is effective January 19, 2010

The Securities and Exchange Commission (“Commission” or “SEC”) is adopting amendments to certain rules that govern money market funds under the Investment Company Act of 1940. The amendments will tighten the risk-limiting conditions of rule 2a-7 by, among other things, requiring funds to maintain a portion of their portfolios in instruments that can be readily converted to cash, reducing the maximum weighted average maturity of portfolio holdings, and improving the quality of portfolio securities; require money market funds to report their portfolio holdings monthly to the Commission; and permit a money market fund that has “broken the buck” (i.e., re-priced its securities below $1.00 per share), or is at imminent risk of breaking the buck, to suspend redemptions to allow for the orderly liquidation of fund assets. The amendments are designed to make money market funds more resilient to certain short-term market risks, and to provide greater protections for investors in a money market fund that is unable to maintain a stable net asset value per share.

Effective Date: The rules, rule amendments, and form are effective May 5, 2010. The expiration date for 17 CFR 270.30b1-6T is extended from September 17, 2010 to December 1, 2010. Compliance dates are discussed in Section III of the Supplementary Information.

This rule finalizes amendments to the Food Stamp Program (FSP) regulations that were proposed in a Notice of Proposed Rulemaking (NPRM), ‘‘Food Stamp Program High Performance Bonuses’’, published on December 17, 2003 in the Federal Register. The NPRM proposed regulations that would implement section 4120 of the Farm Security and Rural Investment Act of 2002 (FSRIA) which authorized the Food and Nutrition Service (FNS) to award bonuses to States that demonstrate high or improved performance in administering the FSP. The NPRM proposed performance measures for the high performance bonuses for fiscal year (FY) 2005 and beyond. It also proposed the data that would be used to measure the identified performance. This final rule summarizes and discusses the comments we received as well as adjusts the regulatory language when necessary in response to those comments.

Effective Date: This final rule is effective April 8, 2005. The provisions of this final rule are required to be implemented no later than April 8, 2005.

This rule finalizes the proposed provisions of a rule published on March 19, 2004 to amend Food Stamp Program regulations to codify Food Stamp Employment and Training (E&T) Program provisions of section 4121 of the Farm Security and Rural Investment Act of 2002 (the Farm Bill). This final rule establishes a reasonable formula for allocating the 100 percent Federal grant authorized under the Farm Bill to carry out the E&T Program each fiscal year. This final rule also codifies the Farm Bill provision that makes available up to $20 million a year in additional unmatched Federal E&T funds for State agencies that commit to offer an education/training or workfare opportunity to every applicant and recipient who is an able-bodied adult without dependents (ABAWD), limited to 3 months of food stamp eligibility in a 36-month period, who would otherwise be terminated. This final rule eliminates the current Federal costsharing cap of $25 per month on the amount State agencies may reimburse E&T participants for work expe ses other than dependent care. This final rule codifies Farm Bill provisions that expand State flexibility in E&T Program spending by repealing the requirements that State agencies earmark 80 percent of their annual 100 percent Federal E&T grants to serve ABAWDs; they meet or exceed their fiscal year 1996 State administrative spending levels to access funds made available by the Balanced Budget Act of 1997; and the Secretary be given the authority to establish maximum reimbursement costs of E&T Program components. Lastly, this final rule rescinds the balance of unobligated funds carried over from fiscal year 2001.

Effective Date: This final rule is effective August 8, 2006.

This final rule amends regulations for the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) by adding three requirements mandated by the Child Nutrition and WIC  Reauthorization Act of 2004 in amendments to the Child Nutrition Act of 1966 (CNA) concerning retail vendors authorized by WIC State agencies to provide supplemental food to WIC participants in exchange for WIC food instruments. The intent of these provisions is to enhance due process for vendors; prevent defective infant formula from being consumed by infant WIC participants; and ensure that the WIC Program does not pay the cost of incentive items provided by above-50- percent vendors in the form of high food prices. Finally, this rule also adjusts the vendor civil money penalty (CMP) levels to reflect inflation.

Effective Date: This rule is effective March 9, 2009

According to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

According to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

An evaluation of each food hazard identified to determine if the hazard is reasonably likely to occur and thus, constitutes a food hazard that must be addressed in the HACCP plan.

The Food and Drug Administration (FDA) is amending the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (the PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer will file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer will receive a biologics license to market the product in interstate commerce. This action is part of FDA’s continuing effort to achieve the objectives of the President’s ‘‘Reinventing Government’’ initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action implements certain sections of the FDA Modernization Act of 1997 (FDAMA).

Effective Date: The regulation is effective December 20, 1999

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled ‘‘Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.’’ FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Effectice Date: This rule becomes effective September 7, 2007. The classification of this device into class II became effective on September 26, 2001.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, August 25, 2008 (73 FR 49941). The final rule made technical amendments to several FDA regulations. The document was published with two inaccurate citations in the first paragraph of the Background Section under Supplementary Information. This document corrects that error.

Effective Date:  This rule is  effective September 19, 2008

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency’s final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted previously.

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency’s final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted previously.

The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediatesize patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.

Effective Date: This rule is effective October 13, 2009

The Hazard Analysis Critical Control Point system (HACCP) has become the universally recognized and accepted method for food safety assurance. The recent and growing concern about food safety from public health authorities, food industry and consumers worldwide has been the major impetus in the application of the HACCP system. This concern has been substantiated by a significant increase in the incidence of foodborne diseases in many countries during recent years.

According to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

Aaccording to current Good Manufacturing Practice (GMP), Part 820 of the QS regulation states that medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations.

The Minister of Health has, in terms of section 61(1)(c) of the Health Professions Act, 1974 (Act No. 56 of 1974), in consultation with the Health Professions Council of South Africa, made the regulations in the Schedule.