Compliance Regulations and Guidance Affecting your Industry

The Electronic Fund Transfer Act (EFTA) (15 USC 1693 et seq.) of 1978 is intended to protect individual consumers engaging in electronic fund transfers (EFTs). EFT services include transfers through automated teller machines, point-of-sale terminals, automated clearinghouse systems, telephone bill-payment plans in which periodic or recurring transfers are contemplated, and remotebanking programs.

The Board amended Regulation E to add § 205.17, prohibiting institutions from charging overdraft fees for ATM and point of sale (POS) transactions unless the consumer affirmatively consents (74 Fed. Reg. 59033 (Nov. 17, 2009) and 75 Fed. Reg 31665 June 4, 2010). The Board also added § 205.20 to restrict fees and expiration dates on gift cards, and to require that gift card terms be clearly stated (75 Fed. Reg. 16580 (April 1, 2010).

Securities Act, the Exchange Act primarily regulates transactions of securities in the secondary market - that is, sales that take place after a security is initially offered by a company (the issuer).  These transactions often take place between parties other than the issuer, such as trades that retail investors execute through brokerage firms.  The Exchange Act operates somewhat differently from the Securities Act.  To protect investors, Congress crafted a mandatory disclosure process that is designed to force companies to make public information that investors would find pertinent to making investment decision.  In addition, the Exchange Act provides for direct regulation of the markets on which securities are sold (the securities (stock) exchanges) and the participants in those markets (industry associations, brokers, and issuers).

The Banking Regulation Act was passed as the Banking Companies Act 1949 and came into force wef 16.3.49. Subsequently it was changed to Banking Regulations Act 1949 wef 01.03.66. The Central Government, if on a representation made by the Reserve Bank in this behalf it is satisfied that it is expedient so to do, may by notification in the Official Gazette, suspend for such period, not exceeding sixty days, as may be specified in the notification, the operation of all or any of the provisions of this Act, either generally or in relation to any specified banking company.

Fair Credit Reporting Act includes the amendments to the FCRA set forth in the Consumer Credit Reporting Reform Act of 1996 (Public Law 104-208, the Omnibus Consolidated Appropriations Act for Fiscal Year 1997, Title II, Subtitle D, Chapter 1), Section 311 of the Intelligence Authorization for Fiscal Year 1998 (Public Law 105-107), the Consumer Reporting Employment Clarification Act of 1998 (Public Law 105-347), Section 506 of the Gramm-Leach- Bliley Act (Public Law 106-102), Sections 358(g) and 505(c) of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act) (Public Law 107-56), and the Fair and Accurate Credit Transactions Act of 2003 (FACT Act) (Public Law 108-159).

The Affordable Health Care for America Act was introduced in the U.S. House of Representatives on October 29, 2009. The following summary of H.R. 3962 describes key components of this health reform legislation focusing on provisions to expand health coverage, control health care costs, and improve the health care delivery system. This summary will be updated to reflect changes made during the legislative process. It requires individuals to have health insurance. Create a Health Insurance Exchange through which individuals and smaller employers can purchase health coverage, with premium and cost-sharing credits available to individuals/families with incomes up to 400% of the federal poverty level (or $73,240 or a family of three in 2009). Require employers to provide coverage to employees or pay into a Health Insurance Exchange Trust Fund, with exceptions for certain small employers, and provide certain small employers a credit to offset the costs of providing coverage. Impose new regulations on plans participating in the Exchange and in the small group insurance market.

This act promote the financial stability of the United States by improving accountability and transparency in the financial system, to end ‘‘too big to fail’’, to protect the American taxpayer by ending bailouts, to protect consumers from abusive financial services practices, and for other purposes.

The Dodd-Frank law tries to restructure US regulation to force regulators to consider institutions in the light of what they do - rather than what they nominally are. So AIG would be considered as a financial institution selling risky credit default swaps - rather than just an insurer. Plus, an asset bubble should be considered not in isolation but in terms of the impact it could have in other asset classes.

• Foreign banks operating federal branches or agencies shall operate under the same rights and privileges as national banks, subject to certain restrictions.
• With the approval of the Comptroller and the Board, a foreign bank with a branch or agency in one state (the home state) may establish and operate a federal branch or agency in another state (the host state) as allowed by host state law as permitted under Section 44 of the Federal Deposit Insurance Act.
• With the approval of the appropriate state regulator and the Board, a foreign bank with a branch or agency in one state (the home state) may establish and operate a state licensed branch or agency in another state (the host state) as allowed by host state law as permitted under Section 44 of the Federal Deposit Insurance Act.
• No federal or state licensed branch offices in the United States may recieve deposits of less than $100,000 unless the branch is an insured branch underSection 3(s) of the Federal Deposit Insurance Act.
• Subject to certain limitations, the Comptroller has all powers over foreign banks with branches or agencies in a state that it has over national banks operating in that state.

This guidance for industry provides the Agency’s current thinking on how to evaluate out-of-specification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.
 

This guidance applies to chemistry-based laboratory testing of drugs regulated by CDER. It is directed toward traditional drug testing and release methods. These laboratory tests are performed on active pharmaceutical ingredients, excipients and other components, in-process materials, and finished drug products3 to the extent that current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) and the Federal Food, Drug, and Cosmetic Act (the Act) (section 501(a)(2)(B)) apply. The principles in this guidance also apply to in-house testing of drug product components that are purchased by a firm. This guidance can also be used by contract firms performing production and/or laboratory testing responsibilities. Specifically, the guidance discusses how to investigate OOS test results, including the responsibilities of laboratory personnel, the laboratory phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the laboratory, and the final evaluation of all test results.

The Trust Indenture Act of 1939 was passed for the protection of bond investors. In the event that a bond issuer becomes insolvent, the appointed trustee may be given the right to seize the bond issuer's assets and sell them in order to recoup the bondholders' investments.

This  law passed in 1939 that prohibits bond issues valued at over $5 million from being offered for sale without a formal written agreement (an indenture), signed by both the bond issuer and the bondholder, that fully discloses the particulars of the bond issue. The act also requires that a trustee be appointed for all bond issues, so that the rights of bondholders are not compromised.

This guidance is intended to address two topics pertaining to Medication Guides for drug and biological products. This guidance applies when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient. The guidance also clarified when a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).

This guidance provides guidelines for implementing agencies that conduct inspections of facilities (i.e., stationary sources) subject to 40 CFR Part 68, also called the EPA Risk Management Program. It is designed as a tool for inspectors reviewing industry compliance with the Risk Management Program regulation. However, this guidance does not reflect all requirements that a facility must meet to be in compliance with the regulation.
 

The Environmental Protection Agency (EPA) works closely with stakeholders to reduce the likelihood and severity of chemical accidents.Several important planning and legislative initiatives have been introduced since 1968. These include the National Contingency Plan (NCP) (started in 1968), EPA’s voluntary Chemical Emergency Preparedness Program started after the December 1984 accident in Bhopal (India), the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), and the Accidental Release Prevention requirements under Section 112(r) of the Clean Air Act (CAA), as amended in 1990. These initiatives address the entire safety continuum dealing with chemical accident preparedness, response, and prevention.

This guidance provides guidelines for implementing agencies that conduct inspections of facilities (i.e., stationary sources) subject to 40 CFR Part 68, also called the EPA Risk Management Program. It is designed as a tool for inspectors reviewing industry compliance with the Risk Management Program regulation. However, this guidance does not reflect all requirements that a facility must meet to be in compliance with the regulation.
 

The Environmental Protection Agency (EPA) works closely with stakeholders to reduce the likelihood and severity of chemical accidents.Several important planning and legislative initiatives have been introduced since 1968. These include the National Contingency Plan (NCP) (started in 1968), EPA’s voluntary Chemical Emergency Preparedness Program started after the December 1984 accident in Bhopal (India), the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), and the Accidental Release Prevention requirements under Section 112(r) of the Clean Air Act (CAA), as amended in 1990. These initiatives address the entire safety continuum dealing with chemical accident preparedness, response, and prevention.

This guidance document summarizes and explains the basic requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) for exporting human drugs, animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be sold or distributed in the United States. This law amended sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (the Act), as well as section 351(h) of the Public Health Service Act, simplifying the requirements for exporting unapproved human drugs, biological products, and devices. In addition, the FDA Export Reform and Enhancement Act substantially reduced the requirements for exporting unapproved new animal drugs and provided a new option for exporting unapproved devices.

The 1996 Amendments did not change the general export requirements in section 801(e)(1) of the Act with respect to foods or cosmetics. This document provides guidance on these general export requirements under section 801(e)(1) of the Act for all products that are subject to this provision. Guidance is also provided on the export requirements for unapproved human drugs, biological products and devices in sections 801 and 802 of the Act resulting from the 1996 Amendments.

The Department of Agriculture is moving the Forest Service’s National Environmental Policy Act (NEPA) codifying procedures from Forest Service Manual (FSM) 1950 and Forest Service Handbook (FSH) 1909.15. In addition to codifying the procedures,the Department is clarifying and expanding them to incorporate Council on Environmental Quality (CEQ) guidance and to better align Forest Service NEPA procedures with its decision processes.

This rule gives Forest Service NEPA procedures more visibility, consistent with the transparent nature of the Forest Service’s environmental analysis and decision making. Also, the additions to the Forest Service NEPA procedures in this rule are intended to provide an environmental analysis process that better fits with modern thinking on decisionmaking, collaboration, and adaptive management by describing a process for incremental alternative development and development ofadaptive management alternatives. Maintaining Forest Service explanatory guidance in the FSH will facilitate timely responses to new ideas, new information, procedural interpretations,training needs, and editorial changes to assist field units when implementing the NEPA process.

Effective Date: These NEPA procedures are effective July 24, 2008.

This final rule clarifies policies relating to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions who present to a hospital under the provisions of the Emergency Medical Treatment and Labor Act (EMTALA).

The final rule responds to public comments received on a May 9, 2002 proposed rule (67 FR 31404) that both reiterated the agency’s interpretations under EMTALA and proposed clarifying changes relating to the implementation of the EMTALA provisions. These reiterations and clarifying changes related to, among other areas, seeking prior authorization from insurers for services, emergency patients presenting at off-campus outpatient clinics that do not routinely provide emergency services, the applicability of the EMTALA provisions to hospital inpatients and outpatients, the circumstances under which physicians must serve on hospital medical staff “on-call” lists, and the responsibilities of hospital-owned ambulances.

The Resource Conservation and Recovery Act (RCRA) give EPA the authority to control hazardous waste from the "cradle-to-grave." This includes the generation, transportation, treatment, storage, and disposal of hazardous waste. RCRA also set forth a framework for the management of non-hazardous solid wastes. The 1986 amendments to RCRA enabled EPA to address environmental problems that could result from underground tanks storing petroleum and other hazardous substances.

The Lacey Act (16 U.S.C. 3371) first enacted in 1900 and significantly amended in 1981, is the United States’ oldest wildlife protection
statute. The Act combats trafficking in ‘‘illegal’’ wildlife, fish, or plants. The Food, Conservation, and Energy Act of 2008, effective May 22, 2008, amended the Lacey Act by expanding its protection to a broader range of plants and plant products (Section 8204, Prevention of Illegal Logging Practices).

The Food, Conservation, and Energy Act of 2008 amended the Lacey Act to provide, among other things, that importers submit a declaration at the time of importation for certain plants and plant products. The declaration requirements of the Lacey Act became effective on December 15, 2008, and enforcement of those requirements is being phased in. The purpose of this notice is to inform the public of the Federal Government’s revised plan to phase in enforcement of the declaration requirement and other implementation plans.

This guideline informs interested persons on certain practices and procedures for the preparation of investigational new drug products for human and animal use that may be useful to persons seeking to comply with certain sections of the current good manufacturing practices (CGMP) regulations for finished pharmaceuticals (Title 21 of the Code of Federal Regulation, Parts 210 and 211)

 

Signed by President Lyndon B. Johnson on September 24, 1965, the Executive Order 11246 establishes the significance for Equal Employment Opportunity. Prohibiting the “federal contractors and federally assisted construction contractors and subcontractors, who do over $10,000 in Government business in one year from discriminating in employment decisions on the basis of race, color, religion, sex, or national origin", the Order ensures that the Contractors "take affirmative action to ensure that applicants are employed, and that employees are treated during employment, without regard to their race, color, religion, sex or national origin”.

CLICK HERE to view the Regulation.

This guidance explains how your business may qualify as a “small business” and pay most FY 2011 medical device user fees at substantially discounted rates; if you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).