Compliance Regulations and Guidance Affecting your Industry

The Payment Card Industry (PCI) Data Security Standard (DSS) was developed to encourage and enhance cardholder data security and facilitate the broad adoption of consistent data security measures globally. This document, PCI Data Security Standard Requirements and Security Assessment Procedures, uses as its foundation the 12 PCI DSS requirements, and combines them with corresponding testing procedures into a security assessment tool. It is designed for use by assessors conducting onsite reviews for merchants and service providers who must validate compliance with the PCI DSS. Below is a high-level overview of the 12 PCI DSS requirements. The next several pages provide background about preparing for, conducting, and reporting a PCI DSS assessment, whereas the Detailed PCI DSS Requirements begin on page 13.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic and replaces FDA’s previous guidance on exports entitled, “A Review of FDA’s Implementation of the Drug Export Amendments of 1986.” 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.

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 the availability of a guidance entitled ‘‘PET Drugs—Current Good Manufacturing Practice (CGMP).’’ Elsewhere in this issue of the Federal Register, we are issuing final regulations on CGMPs for positron emission tomography (PET) drugs. We are issuing the guidance to help PET drug producers better understand FDA’s thinking concerning compliance with the PET CGMP regulations.

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.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Patient-Reported 
Outcome Measures: Use in Medical Product Development to Support 
Labeling Claims.'' This guidance describes how FDA reviews and 
evaluates patient-reported outcome (PRO) instruments used to measure 
treatment benefit in medical product clinical trials. It also provides 
recommendations on how sponsors can use study results measured by PRO 
instruments to support claims in approved medical product labeling. 
This guidance finalizes the draft guidance published on February 3, 
2006.

DATES: Submit written or electronic comments on agency guidances at any 
time.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering- Plough Animal Health Corp. to Janssen Pharmaceutica NV.

Effective Date: This rule is effective December 11, 2009
 

The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled ‘‘PET Drugs—Current Good Manufacturing Practice (CGMP).

Effective Date:This rule is effective August 14, 2009 The General Services Administration is amending the Federal  Management Regulation (FMR) by making a change to its personal property  policy. This final rule updates and clarifies language that has caused  some confusion with our customers and resulted in unnecessarily  prolonged periods to remove property.

Effective Date:This rule is effective August 14, 2009

The General Services Administration is amending the Federal Management Regulation (FMR) by making a change to its personal property policy. This final rule updates and clarifies language that has caused some confusion with our customers and resulted in unnecessarily prolonged periods to remove property

The General Services Administration is amending the Federal Management Regulation (FMR) by making a change to its personal property 
policy. This final rule updates and clarifies language that has caused some confusion with our customers and resulted in unnecessarily 
prolonged periods to remove property.

DATES: Effective Date: This final rule is effective on August 14, 2009.

The General Services Administration is amending the Federal Management Regulation (FMR) by updating coverage on the replacement of 
personal property pursuant to the exchange/sale authority. The changes were prompted by recommendations of

DATES:  This final rule is effective August 29, 2008.

The General Services Administration is amending the Federal Management Regulation (FMR) by revising coverage on personal property 
and moving it into subchapter B of the FMR. This final rule adds a new part to subchapter B of the FMR to provide an overview of the property 
disposal regulation and provide definitions for terms found in the FMR .
parts.

SUMMARY: The General Services Administration is amending the Federal Management Regulation (FMR) by correcting references to outdated or 
superceded provisions of law or regulation; correcting text to be in conformance with revised laws, regulation, or Federal agency 
responsibilities; and clarifying text where the intended meaning could be updated or made clearer.

DATES: Effective Date: October 12, 2006.

Federal Management Regulation (FMR) - Annual Real Property Inventories 102-84

The FMR is the successor regulation to the Federal Property Management Regulation (FPMR). It contains updated regulatory policies originally found in the FPMR. However, it does not contain FPMR material that described how to do business with the GSA. Its Subchapter C—Real Property  talks about Annual Real Property Inventories   102-84.

Federal Management Regulation (FMR) - Location of Space  102-83

The FMR is the successor regulation to the Federal Property Management Regulation (FPMR). It contains updated regulatory policies originally found in the FPMR. However, it does not contain FPMR material that described how to do business with the GSA. Its Subchapter C—Real Property  talks about Location of Space  102-83.This part has Two sub-parts as follows-

Subpart A—General Provisions   
Subpart B—Location of Space

Federal Management Regulation (FMR) - Utility Services 102-82

The FMR is the successor regulation to the Federal Property Management Regulation (FPMR). It contains updated regulatory policies originally found in the FPMR. However, it does not contain FPMR material that described how to do business with the GSA. Its Subchapter C—Real Property  talks about Utility Services 102-82.This part has Two sub-parts as follows-

Subpart A—General Provisions   
Subpart B—Utility Services

Federal Management Regulation (FMR) - Security 102-81

The FMR is the successor regulation to the Federal Property Management Regulation (FPMR). It contains updated regulatory policies originally found in the FPMR. However, it does not contain FPMR material that described how to do business with the GSA. Its Subchapter C—Real Property  talks about Security 102-81.This part has Two sub-parts as follows-

Subpart A—General Provisions   
Subpart B—Security

Federal Management Regulation (FMR) - Safety and Environmental Management  102-80

The FMR is the successor regulation to the Federal Property Management Regulation (FPMR). It contains updated regulatory policies originally found in the FPMR. However, it does not contain FPMR material that described how to do business with the GSA. Its Subchapter C—Real Property  talks about Safety and Environmental Management  102-80.This part has Three sub-parts as follows-

Subpart A—General Provisions   
Subpart B—Safety and Environmental Management
Subpart C—Accident and Fire Prevention

Federal Management Regulation (FMR) - Assignment and Utilization of Space 102-79

The FMR is the successor regulation to the Federal Property Management Regulation (FPMR). It contains updated regulatory policies originally found in the FPMR. However, it does not contain FPMR material that described how to do business with the GSA. Its Subchapter C—Real Property  talks about Assignment and Utilization of Space 102-79.This part has Two sub-parts as follows-

Subpart A—General Provisions   
Subpart B—Assignment and Utilization of Space