Compliance Regulations and Guidance Affecting your Industry

This final rule will set forth the hospice wage index for fiscal year 2010. The final rule adopts a MedPAC recommendation regarding a process for certification and recertification of terminal illness. In addition, this final rule will also revise the phase-out of the wage index budget neutrality adjustment factor (BNAF), with a 10 percent BNAF reduction in FY 2010. The BNAF phase-out will continue with successive 15 percent reductions from FY 2011 through FY 2016

This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1). The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules

This is one in a series of guidance documents intended to assist persons making regulatory submissions to FDA in electronic format. This guidance is designed to assist manufacturers with electronic submissions of drug establishment registration and drug listing information. The guidance and accompanying technical documents explain (among other things): • The statutory requirement to submit electronically drug establishment registration and drug listing information; • How to create a Structured Product Labeling (SPL)2 file for submitting drug establishment registration and drug listing information to FDA through the Electronic Submissions Gateway (ESG) using defined code sets and codes, i.e., a language recognized by the computer system; and • Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted. FDA intends to update these documents regularly to reflect the evolving technology and user experience.

The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational changes in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency’s regulations

Effective Date:This rule is effective April 1,2009.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Investigator Responsibilities— Protecting the Rights, Safety, and Welfare of Study Subjects.’’ This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA’s expectations concerning the investigator’s responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties

This document is intended to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462, 120 Stat. 3469). The statute created a new section 502(x) in the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(x)). These requirements apply to manufacturers, packers, and distributors of nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application. In particular, this document covers the following topics: (1) the meaning of domestic address for purposes of the labeling requirements of section 502(x) of the Act, (2) FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the Act, and (3) FDA’s intent regarding enforcing the labeling requirements of section 502(x) of the Act

This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. Although not specifically required, the pharmacologic class can also appear in other sections of labeling. This guidance only applies to the use of the pharmacologic class in the Indications and Usage section of Highlights

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

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

This document contains temporary regulations that provide further guidance and clarification regarding methods under section 482 to determine taxable income in connection with a cost sharing arrangement in order to address issues that have arisen in administering the current regulations. The temporary regulations affect domestic and foreign entities that enter into cost sharing arrangements described in the temporary regulations. The text of these temporary regulations also serves as the text of the proposed regulations set forth in the Proposed Rules section in this issue of the Federal Register

Effective Date:This rule is effective  January 5, 2009.

Pension Benefit Guaranty Corporation (PBGC) is amending its Privacy Act regulations to exempt certain records that are maintained in a system of records entitled ‘‘PBGC–17, Office of Inspector General Investigative File System—PBGC’’ from the access, contest, and certain other provisions of the Privacy Act. The amendment protects the information gathered to carry out the Office of Inspector General’s law enforcement mission to investigate criminal, civil, and administrative matters

Effective Date:This rule is effective July 8, 2009

This document contains final and temporary regulations concerning the amendments made by the Tax Increase Prevention and Reconciliation Act of 2005 to section 199 of the Internal Revenue Code. The temporary regulations also contain a rule concerning the use of losses incurred by members of an expanded affiliated group. Section 199 provides a deduction for income attributable to domestic production activities. The regulations will affect taxpayers engaged in certain domestic production activities. The text of the temporary regulations also serves as the text of the proposed regulations set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the Federal Register.

This document contains corrections to final regulations (TD 9408) that were published in the Federal Register on Wednesday, July 2, 2008 (73 FR 37797), relating to a claim that a child is a dependent by parents who are divorced, legally separated under a decree of separate maintenance, or separated under a written separation agreement, or who live apart at all times during the last 6 months of the calendar year

The Office of Foreign Assets Control (OFAC) of the U.S. Department of the Treasury is issuing this final rule, ‘‘Economic Sanctions Enforcement Guidelines,’’ as enforcement guidance for persons subject to the requirements of U.S. sanctions statutes, Executive orders, and regulations. This rule was published as an interim final rule with request for comments on September 8, 2008. This final rule sets forth the Enforcement Guidelines that OFAC will follow in determining an appropriate enforcement response to apparent violations of U.S. economic sanctions programs that OFAC enforces. These Enforcement Guidelines are published as an Appendix to the Reporting, Procedures and Penalties Regulations.

Effective Date:This rule is effective November 9, 2009

The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA’s usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this directfinal rule

Effective Date:This rule is effective December 7, 2009

The Food and Drug Administration (FDA) is confirming the effective date of September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. The rule provides that FDA will publish a notice in the Federal Register following revocation of a biologics license under FDA regulations and will include a statement of the specific grounds for the revocation. This document confirms the effective date of the direct final rule

Effective Date:This rule is effective September 17, 2009

The Food and Drug Administration (FDA or the agency) is announcing the availability of a guidance for industry #187 entitled ‘‘Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs.’’ This guidance is intended to clarify FDA’s requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA’s intent to exercise enforcement discretion regarding requirements for certain GE animals

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule

Effective Date:This rule is effective February 19, 2008

The Food and Drug Administration (FDA) is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus (HCV) infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus (HIV) ‘‘lookback’’ requirements for greater consistency with the HCV ‘‘lookback’’ requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ‘‘Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV’’ (the ‘‘lookback’’ guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services (CMS) elsewhere in this issue of the Federal Register.

Effective Date:This rule is effective February 20, 2008

The Food and Drug Administration is correcting a direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). That document amended the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. A proposal was published as a companion document to the direct final rule in the same issue of the Federal Register (August 16, 2007, 72 FR 45993). Both documents published with a typographical error in the codified section. This document corrects the error in the direct final rule. Elsewhere in this issue of the Federal Register we are correcting the error in the proposed rule

Effective Date:This rule is effective February 19, 2008