Compliance Regulations and Guidance Affecting your Industry

The Food and Drug Administration (FDA) is announcing amendments to the two Emergency Use Authorizations (EUAs) (the Authorizations) for certain products from the neuraminidase class of antivirals, zanamivir and oseltamivir phosphate, issued on April 27, 2009, under the Federal Food, Drug,  and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). On  July 14, 2009, in response to a request from CDC, FDA amended and reissued in its entirety the Authorization for certain oseltamivir phosphate products. On October 30, 2009, in response to a request   from CDC, among other reasons, FDA amended and reissued in their entirety the Authorization letters for certain zanamivir and oseltamivir phosphate products. Finally, on November 4, 2009, FDA amended and reissued in its entirety the Authorization letter for certain zanamivir inhalation powder. The Authorization letter for certain oseltamivir phosphate products, as amended on October 30, 2009, and the Authorization letter for certain zanamivir inhalation powder, as amended on November 4, 2009, including explanations for their reissuance, are reprinted in this document.

DATES: The amended Authorizations are effective as of October 30, 2009.

 

The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for peramivir injection 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients issued on October 23, 2009, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). FDA received inquiries related to the recommended dosing for patients with renal impairment. On November 19, 2009, FDA amended the Authorization letter and reissued the Authorization letter in its entirety to provide additional clarification. The Authorization letter, as amended and reissued, which includes explanations for its reissuance, is reprinted in this notice.

DATES: The amended Authorization is effective as of November 19, 2009.

 

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 26, 2010.

 

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by May 20, 2010.

 

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each  proposed collection of  information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA’s collection of information from local, State, and tribal governmental agencies concerning their adoption of, or plans to adopt, all or portions of the FDA Food Code or its equivalent by regulation, law, or ordinance.

DATES: Submit written or electronic comments on the collection of information by June 14, 2010.

 

The Food and Drug Administration (FDA) has determined the regulatory review period for SAVELLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

This establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

Effective Date: This rule is effective April 28, 2010. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.

The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of April 28, 2010.

 

This guidance represents the Food and Drug Administration's (FDA'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. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Effective Date: Fax written comments on the collection of information by June 1, 2010.

 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of an injectable solution of butorphanol tartrate in cats for the relief of pain.

Effective Date: This rule is effective April 29, 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: January 19, 2010.

We are amending rules under the Securities Exchange Act of 1934 and the Securities Act of 1933 to clarify and provide additional flexibility regarding the format of the Notice of Internet Availability of Proxy Materials that is sent to shareholders and to permit issuers and other soliciting persons to better communicate with shareholders by including explanatory materials regarding the reasons for the use of the notice and access proxy rules and the process of receiving and reviewing proxy materials and voting pursuant to the notice and access proxy rules. The amendments also revise the timeframe for delivering a Notice to shareholders when a soliciting person other than the issuer relies on the notice and access proxy rules and permit mutual funds to accompany the Notice with a summary prospectus.

Effective Date: March 29, 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.

Dates: 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.

 

We are making technical corrections to amendments to our disclosure rules adopted in Release No. 33-9089 (December 16, 2009), which was published in the Federal Register on December 23, 2009 (74 FR 68334). Specifically, we are correcting Forms 10-Q and 10-K to retain the current numbering of the items appearing in each form to avoid confusion that might otherwise arise from references to the current numbering in professional literature. In addition, we are making three corrections to Form 8-K. We are correcting Form 8-K to add an instruction, which was inadvertently excluded, that corresponds to an instruction contained in Forms 10-Q and 10-K that allows certain wholly-owned subsidiaries to omit the disclosure of shareholder voting results. We also are correcting Form 8-K to amend the regulatory text to make it consistent with the discussion of the amendments to that form contained in Release No. 33-9089.

Effective Date: February 28, 2010.

 

The Securities and Exchange Commission (“Commission”) is adopting amendments to Regulation SHO under the Securities Exchange Act of 1934 (“Exchange Act”). We are adopting a short sale-related circuit breaker that, if triggered, will impose a restriction on the prices at which securities may be sold short (“short sale price test” or “short sale price test restriction”). Specifically, the Rule requires that a trading center establish, maintain, and enforce written policies and procedures reasonably designed to prevent the execution or display of a short sale order of a covered security at a price that is less than or equal to the current national best bid if the price of that covered security decreases by 10% or more from the covered security’s closing price as determined by the listing market for the covered security as of the end of regular trading hours on the prior day. In addition, the Rule requires that the trading center establish, maintain, and enforce written policies and procedures reasonably designed to impose this short sale price test restriction for the remainder of the day and the following day when a national best bid for the covered security is calculated and disseminated on a current and continuing basis by a plan processor pursuant to an effective national market system plan. We believe it is appropriate at this time to adopt a short sale-related circuit breaker because, when triggered, it will prevent short selling, including potentially manipulative or abusive short selling, from driving down further the price of a security that has already experienced a significant intra-day price decline, and will facilitate the ability of long sellers to sell first upon such a decline. This approach establishes a narrowly-tailored Rule that will target only those securities that are experiencing significant intra-day price declines. We believe that addressing short selling in connection with such declines in individual securities will help address erosion of investor confidence in our markets generally.

In addition, we are amending Regulation SHO to provide that a broker-dealer may mark certain qualifying sell orders “short exempt.” In particular, if the broker-dealer chooses to rely on its own determination that it is submitting the short sale order to the trading center at a price that is above the current national best bid at the time of submission or to rely on an exception specified in the Rule, it must mark the order as “short exempt.” This “short exempt” marking requirement will aid surveillance by self-regulatory organizations (“SROs”) and the Commission for compliance with the provisions of Rule 201 of Regulation SHO.

Effective Date: May 10, 2010

 

The Securities and Exchange Commission (the Commission) is adopting revisions to the Electronic Data Gathering, Analysis, and Retrieval System (EDGAR) Filer Manual to reflect updates to the EDGAR system. Revisions were are being made primarily to support the upgrade of the Mutual Fund Risk/Return Summary Taxonomy, to extend the interactive data/eXtensible Business Reporting Language (“XBRL”) validation requirements to all Exhibit 101 attachments regardless of the taxonomy used, and to make minor updates to the validation and processing of Form D submissions and the amendments of 13F-HR and 13F-NT submission types.

The EDGAR system is scheduled to be upgraded to support this functionality on April 12, 2010. The filer manual is also being revised to address minor changes previously made in EDGAR. The revisions to the Filer Manual reflect changes within Volume II entitled EDGAR Filer

Manual, Volume II: “EDGAR Filing,” Version 14 (April 2010). The updated manual will be incorporated by reference into the Code of Federal Regulations.

Effective Dates: April 8, 2010. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of April 8, 2010.

 

To add fairness, consistency, and transparency to the future civil penalty determinations, the Federal Energy Regulatory Commission (FERC) has issued this Policy Statement on Penalty Guidelines on March 18, 2010.

The Federal Energy Regulatory Commission of the United States of America has issued Mandatory Reliability Standards for the Bulk Power System on March 18, 2010.

Ensure plans are established and personnel are prepared to enable effective coordination of the System restoration process to ensure reliability is maintained during restoration and priority is placed on restoring the Interconnection

The Reliability Coordinator must have a coordinating role in system restoration to ensure reliability is maintained during restoration and priority is placed on restoring the Interconnection

Effective Date: This rule is effective January 1, 2007