Compliance Regulations and Guidance Affecting your Industry

State of California Department  Of Managed Health Care has Propsed has new regulation on discount helath plan.This plan will help people to recive discount on health care and services.

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. An alternative approach may be used if such 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 issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

Effective Date: This rule is effective August 24, 2007

The Food and Drug Administration (FDA) is amending its food labeling regulations to establish requirements for the identification of dietary supplements and for their nutrition labeling and ingredient labeling in response to the Dietary Supplement Health and Education Act of 1994 (the DSHEA). FDA is also responding to a citizen petition from the Council for Responsible Nutrition on type size requirements for these products. In addition, FDA is announcing the revocation of Compliance Policy Guide 530.400 (CPG 7121.02) entitled ‘‘Vitamin Products for Human Use—Low Potency’’ to eliminate inconsistencies with the new labeling requirements

Effective Date: The regulation is effective March 23, 1999. The Director of the Office of the Federal Register approves the incorporations by reference in accordance with 5 U.S.C. 552(a) and 1CFR part 51 of certain publications in 21CFR 101.4(h), effective March 23, 1999

The Secretary amends the Federal Perkins Loan (Perkins Loan) Program, Federal Family Education Loan (FFEL) Program, and William D. Ford Federal Direct Loan (Direct Loan) Program regulations to implement provisions of the Higher Education Act of 1965 (HEA), as amended by the Higher Education Opportunity Act of 2008 (HEOA), and other recently enacted legislation

Effective Date: This rule is effective July 1, 2010

On January 29, 2009, the Board published a final rule amending Regulation AA and the staff commentary to the regulation. The substantive requirements in the January 2009 Regulation AA Rule, which were scheduled to go into effect on July 1, 2010, have been superseded by provisions of the Credit Card Accountability Responsibility and Disclosure Act of 2009 (Credit Card Act) that go into effect on February 22, 2010. Elsewhere in this issue of the Federal Register, the Board is implementing these Credit Card Act provisions in a new final rule amending Regulation Z. Accordingly, in order to avoid duplication and inconsistency, the Board is further amending Regulation AA to remove the substantive requirements in the January 2009 Regulation AA Rule. For procedural reasons, these requirements will be removed effective July 1, 2010. However, it is the Board’s intent that the substantive requirements of the January 2009 Regulation AA Rule will not take effect. The Board issued its January 2009 Regulation AA Rule jointly with rules issued by the Office of Thrift Supervision (OTS) and the National Credit Union Administration (NCUA). This final rule applies only to the Board’s Regulation AA and does not affect the rules issued by the OTS and NCUA.

Effective Date: This rule is effective July 1, 2010

This report is required by 49 CFR Part 191. Failure to report may result in a civil penalty not to exceed $100,000 for each violation Form Approved for each day the violation continues up to a maximum of $1,000,000 as provided in 49 USC 60122.

The information collected on this form is required. This form reports occurrences or detection of each failure, malfunction, or defect in an aircraft. We estimate that it will take 1 hour to complete the form. No assurance of confidentiality is promised. Please note that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number associated with this collection is 2120-0008. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave SW, Washington, DC 20591,Attn: Information Collection Clearance Officer, ABA-20

The information collected on this form is necessary to determine applicant eligibility for flight engineer or flight navigator certificates. The information is used to determine certification eligibility. We estimated that it will take 6 minutes to complete the form. The information collection is required to obtain a benefit. The information collected becomes part of the Privacy Act system of records DOT/FAA 847,  Records on Individuals. Please note that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number associated with this collection is 2120-0007. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave SW, Washington, DC 20591, Attn: Information Collection Clearance Officer, A -20.

The information that is submitted is used to improve the Aircraft Certification systems Evaluation Program (ACSEP) including the training associated with the program. Although not mandatory, it is requested that this form be completed within thirty (30) days after the completion of the evaluation
 

This collection of information is for the purpose of issuing a U.S.Type Certificate, Production Certificate, or Supplemental Type Certificate to any applicant meeting the criteriaestablished in 14 CFR part 21. The FAA uses the information to evaluate an applicant's application for a U.S. Type Certificate, Production Certificate, or Supplemental Type Certificate. The information on FAA Form 8110-12, Application for Type Certificate, Production Certificate, or Supplemental Type Certificate is solicited under the authority of 49U.S.C. 44702 as implemented by 14 CFR part 21. The burden associated with completingFAA Form 8110-12 is 48 minutes. Providing this information is mandatory if an applicant wishes to obtain a Type Certificate, Production Certificate, or Supplemental Type Certificate.Confidentiality is neither provided nor necessary. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays acurrently valid OMB control number. The OMB control number associated with this collectionof information is 2120-0018. Comments concerning the burden and suggestions for reducingthe burden should be directed to the FAA at: 800 Independence Ave. SW, Washington, DC 20591, Attn: Information Collection Clearance Officer, ABA-20.

Information on FAA Form 8130-1, Application for Export Certificate of Airworthiness is solicited under the authority of 49 U.S.C. 44103 as implemented by 14 CFR Part 21. The purpose of this information is to evaluate an applicant's application for an export airworthiness approval for a Class I or Class 11 product.

The information collected on this form is required. This form reports occurrences or detection of each failure, malfunction, or defect in an aircraft. We estimate that it will take 1 hour to complete the form. No assurance of confidentiality is promised. Please note that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
 

The reason for collecting this information is to track major maintenance performed on aircraft. The collected information is used as part of the aircraft's historical file. The public reporting burden for this collection of information is estimated to average 30 minutes per response. Responses are mandated by 14 CFR Part 43. Collected information becomes part of the public record and no confidentiality is required

The information collected on this form is required. This form reports occurrences or detection of each failure, malfunction, or defect in an aircraft. We estimate that it will take 1 hour to complete the form. No assurance of confidentiality is promised. Please note that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

An agency may not conduct or sponsor, and a person is not required to respond, to a collection of information unless it displays a currently valid OMB control number. The OMB control number for this form is 2120-0552. This information is collected by the FAA's Suspected Unapproved Parts (SUP) Program, under the authority of 49 USC 44701.

This information on FAA form 8130-9, Statement of Conformity, is collected for the purpose of obtaining mandatory information by an applicant as stated below. The FAA uses the information to maintain and update the current database for products and parts during the type certification program and for original airworthiness approvals.
 

This final rule makes technical corrections throughout 49 Code of Federal Regulations subtitle B, chapter III. In 2007, the FMCSA moved to 1200 New Jersey Avenue, SE., Washington, DC 20590. This rule changes obsolete references to the old address. In addition, we are making minor editorial changes to correct errors and omissions and improve clarity. This rule does not make any substantive changes to the affected parts of the Federal Motor Carrier Safety Regulations.

Effective Date: This rule is effective October 1, 2007

FMCSA amends the Federal Motor Carrier Safety Regulations (FMCSRs) to require interstate commercial driver’s license (CDL) holders subject to the physical qualification requirements of the FMCSRs to provide a current original or copy of their medical examiner’s certificates to their State Driver Licensing Agency (SDLA). The Agency also requires the SDLA to record on the Commercial Driver License Information System (CDLIS) driver record the selfcertification the driver made regarding the applicability of the Federal driver qualification rules and, for drivers subject to those requirements, the medical certification status information specified in this final rule. Other conforming requirements are also implemented. This action is required by section 215 of the Motor Carrier Safety Improvement Act of 1999 (MCSIA)

Effective Date: This rule is effective January 30, 2009. The incorporation by reference of the September 2007 version of the publication listed in this rule is approved by the Director of the Office of the Federal Register as of December 1, 2008. State compliance is required by January 30, 2012. All CDL holders must comply with the requirement to submit to the SDLA their self-certification on whether they are subject to the physical qualification rules by January 30, 2014

FMCSA amends the New Entrant Safety Assurance Program regulations to raise the standard of compliance for passing the new entrant safety audit. The Agency identifies 16 regulations that are essential elements of basic safety management controls necessary to operate in interstate commerce and makes a carrier’s failure to comply with any one of the 16 regulations anautomatic failure of the safety audit. Additionally, if certain violations are discovered during a roadside inspection, the new entrant now will be subject to expedited actions to correct these deficiencies. The Agency now will also check compliance with the Americans with Disabilities Act and certain household goods-related requirements in the new entrant safety audit, if they apply to the new entrant’s operation. Failure to comply with either of these requirements will not affect the outcome of the safety audit; however, the Agency will take appropriate actions to improve compliance. FMCSA clarifies changes to some of the existing new entrant regulations and establishes a separate new entrant application procedure and safety oversight program for non-North America-domiciled motor carriers. Finally, the Agency has enhanced the quality and availability of its educational and technical assistance (ETA) materials to ensure applicants are knowledgeable about applicable Federal motor carrier safety standards. Because the Agency believes Form MCS–150A— Safety Certification for Application for USDOT Number is not an effective instrument for establishing knowledgeability, it is eliminating that form. FMCSA believes this rule will improve the Agency’s ability to identify at-risk new entrant carriers and ensure deficiencies in basic safety management controls are corrected before the new entrant is granted permanent registration. These changes do not impose additional regulatory requirements on any new entrant carrier because these carriers are already required to comply with all applicable rules49 CFR Parts 365, 385, 387, and 390    FMCSA–2001–11061
 

Effective Date: This rule is effective February 17, 2009