Compliance Regulations and Guidance Affecting your Industry

The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new over-the-counter (OTC) labeling requirements set forth in 21 CFR 201.66 and prepare new labeling. Additional information is available in the guidance for industry Labeling OTC Human Drug Products Questions and Answers.

Significant gains have been made in highlighting the need for best practice in hand hygiene over the last four years. The reduction in MRSA bacteraemia can in part be attributed to the concerted action across the NHS. However, to maintain this and other improvements it is vital that hand hygiene remains high on the patient safety agenda. Improving the hand hygiene of healthcare staff at the point of patient care will reduce healthcare associated infection (HCAI). Hands are a repository for microorganisms that can cause infection. Healthcare staff in all healthcare settings have the greatest chance of transferring these as they move between patients, or different care activities for the same patient. ational and international studies continue to reinforce the fact that infection rates can be significantly reduced, by at least 15 per cent, where a multi-modal strategy has been introduced to improve hand hygiene.1, 2, 3, 4 Significant progress has been made, however hand hygiene compliance still remains lower than it should be.
 

This final rule adopts updated versions of the standards for electronic transactions originally adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This final rule also adopts a transaction standard for Medicaid pharmacy subrogation. In addition, this final rule adopts two standards for billing retail pharmacy supplies and professional services, and clarifies who the ‘‘senders’’ and ‘‘receivers’’ are in the descriptions of certain transactions.

These regulations are effective March 17, 2009 except for the provisions of 45 CFR part 162 Subpart S, which are effective January 1, 2010.

The Board, OTS, and NCUA (collectively, the Agencies) are exercising their authority under section 5(a) of the Federal Trade Commission Act to prohibit unfair or deceptive acts or practices. The final rule prohibits institutions from engaging in certain acts or practices in connection with consumer credit card accounts. The final rule relates to other Board rules under the Truth in Lending Act, which are published elsewhere in today‘s Federal Register. Because the Board has proposed new rules regarding overdraft services for deposit accounts under the Electronic Fund Transfer Act elsewhere in today‘s Federal Register, the Agencies are not taking action on overdraft services at this time. A secondary basis for OTS‘s rule is the Home Owners‘ Loan Act.

The final rule is effective on July 1, 2010.

Section 740.4 of NCUA’s rules requires that a federally insured credit union continuously display the official NCUA sign at every teller station or window where insured funds or deposits are normally received. Section 740.4(c) requires that tellers accepting share deposits for both federally insured credit unions and nonfederally insured credit unions also post a second sign adjacent to the official NCUA sign. The current rule requires this second sign to list each federally insured credit union served by the teller along with a statement that only these credit unions are federally insured. Due to the evolution of shared branch networks it is now difficult for some tellers to comply with this second signage requirement and, accordingly, NCUA is revising the rule to replace the required listing of credit unions with a statement that not all of the credit unions served by the teller are federally insured and that members should contact their credit union if they need more information.

This rule is effective April 3, 2009.

NCUA is amending its Regulatory Flexibility (RegFlex) Program to provide additional flexibility to qualifying federal credit unions (FCUs) when acquiring unimproved land for future expansion. Previously, when an FCU acquired unimproved land for future expansion and did not fully occupy the completed premises within one year, it was required to partially occupy the completed premises within three years or obtain a waiver. This amendment increases the three years to six years for RegFlex FCUs without a waiver. NCUA is also making conforming amendments to its fixed asset rule to be consistent with the RegFlex changes.

The rule is effective April 27, 2009.

The OCC, Board, FDIC, OTS, NCUA, and FTC (Agencies) are publishing these final rules to implement the accuracy and integrity and direct dispute provisions in section 312 of the Fair and Accurate Credit Transactions Act of 2003 (FACT Act) that amended section 623 of the Fair Credit Reporting Act (FCRA). The final rules implement the requirement that the Agencies issue guidelines for use by furnishers regarding the accuracy and integrity of the information about consumers that they furnish to consumer reporting agencies (CRAs) and prescribe regulations requiring furnishers to establish reasonable policies and procedures for implementing the guidelines. These final rules also implement the requirement that the Agencies issue regulations identifying the circumstances under which a furnisher must reinvestigate disputes about the accuracy of information contained in a consumer report based on a direct request from a consumer.

These rules are effective on July 1, 2010.

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).
 

This regulation is divided in to 15 subparts ranging from A to O. This page contains  the underlying requirements of  Subpart B, C, D, E and K of the regulation which deals with Quality System Requirements, Design, Document, Purchasing Control, Production and Process Controls, Labeling and Packaging Control.

NCUA is amending its reporting procedures and record retention requirements to conform regulatory provisions to its new,  Webbased reporting system. The rule incorporates into the regulation a statutory requirement on reporting changes in senior officials  resulting from election or appointments and clarifies requirements on when a credit union files reports with NCUA online. The rule  also provides alternative reporting methods for credit unions unable to submit online reports.

Effective Date: September 1, 2009

NCUA is amending its share insurance rules to: (1) reflect Congress’s extension, until December 31, 2013, of the temporary increase in the standard maximum share insurance amount (“SMSIA”) from $100,000 to $250,000; and (2) finalize the interim final rules on revocable trust accounts, mortgage servicing accounts, and NCUA’s official sign issued in October 2008.

Effective Date: November 30, 2009

Section 741.4 of NCUA’s rules describes the procedures for the capitalization and maintenance of the National Credit Union Share Insurance Fund (NCUSIF). The current rule, however, does not adequately address how credit unions that enter or depart the NCUSIF system in a given calendar year are affected by any NCUSIF premium or deposit replenishment assessments in that same year. NCUA is now adopting amendments to § 741.4 to clarify these procedures. The final rule also adds Appendix A to Part 741, which repeats various examples of the application of § 741.4, as discussed in the preamble to the proposed rule.
 

Effective Date: January 4, 2010

On June 24, 2009, the NCUA published an interim final rule amending its lending rules to create a limited exception to the 20-year
maturity limit on second mortgage loans. The amendment will permit Federal credit unions participating in the Department of the Treasury’s Making Home Affordable Program to modify a second mortgage loan, beyond 20 years, to match the term of a modified first mortgage loan. This rule confirms those amendments as final without change.

Effective Date:  December 24, 2009

The Department of Homeland Security (DHS) is amending its 
regulations governing representation and appearances by, and 
professional conduct of, practitioners in immigration practice before 
its components to: Conform the grounds of discipline and procedures 
regulations with those promulgated by the Department of Justice (DOJ); 
clarify who is authorized to represent applicants and petitioners in 
cases before DHS; remove duplicative rules, procedures, and authority; 
improve the clarity and uniformity of the existing regulations; make 
technical and procedural changes; and conform terminology. This rule 
enhances the integrity of the immigration adjudication process by 
updating and clarifying the regulation of professional conduct of 
immigration practitioners who practice before DHS.

Effective Date : March 4, 2010

The FAA is delaying the compliance date for the final rule clarifying that contractors, including subcontractors at any tier, must be
subject to drug and alcohol testing. This action is necessary because it has cometo our attention that some original equipment manufacturers (OEMs) and other entities may be confused regarding whether they are performing maintenance or preventive maintenance duties subject to drug and alcohol testing, or manufacturing duties not subject to testing. The effective date of April 10, 2006, will remain the same,but this action extends the compliance date until October 10, 2006, which gives OEMs and others sufficient time to determine what work is subject to drug and alcohol testing

Effective Date : The effective date of the final rule published at 71 FR 1666 (January 10, 2006) remains April 10, 2006

This draft guidance, when finalized, will represent 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 the 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

This draft guidance, when finalized, will represent 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 the 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

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 requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The agency is amending the current good manufacturing practice (CGMP) and quality system (QS) regulations that apply to HCT/Ps regulated as drugs, medical devices, and/or biological products to clarify the role of the new donor-eligibility regulations in relation to existing CGMP regulations. By preventing the transmission of communicable disease by the wide spectrum of HCT/Ps that are marketed now or may be marketed in the future, the agency’s action will improve protection of the public health and increase public confidence in new technologies.

Effective Date: This rule is effective May 25, 2005

The Food and Drug Administration (FDA) is correcting a final rule that published in the Federal Register of May 25, 2004 (69 FR 29786). The final rule required human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The document was published with an error in the codified section. This document corrects that error.

Effective Date: This rule is effective March 24, 2006

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is taking this action to complete the rulemaking initiated with the interim final rule

Effective Date: This rule is effective June 19,2007