Compliance Regulations and Guidance Affecting your Industry

The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of ‘‘minor use’’ that relied on the phrase ‘‘small number of animals’’ to characterize such use. At this time, the Food and Drug Administration (FDA) is amending the implementing regulations of the MUMS Act. In response to Congress’ charge to the agency to further define minor use, this amendment establishes a specific ‘‘small number of animals’’ for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use

Effective Date: This rule is effective November 9, 2009

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.’’ The document provides guidance to the dietary supplement industry for complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate guidance on labeling requirements for nonprescription (over-the-counter) human drugs marketed without an approved application, issued by FDA’s Center for Drug Evaluation and Research, is announced elsewhere in this issue of the Federal Register

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.’’ This guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate guidance, issued by the Center for Food Safety and Applied Nutrition on complying with the labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘End-of-Phase 2A Meetings.’’ This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sometribove zinc suspension from Monsanto Co. to Elanco Animal Health, A Division of Eli Lilly & Co

Effective Date:This rule is effective October 16,2009

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.’’ This guidance document describes a means by which wound dressing with Poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify wound dressing with pDADMAC additive into class II (special controls). This guidance document is being immediately implemented as the special control for wound dressing with pDADMAC additive, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and review staff entitled ‘‘Labeling for Human Prescription Drug and Biological Products—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.’’ 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. This guidance finalizes the draft guidance published in the Federal Register on May 16, 2007.

The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. FDA is amending the regulations in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA’s usual procedure for notice-andcomment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and this direct final rule are substantively identical.

Effective Date: This rule is effective March 8,2010

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency’s regulations.

Effective Date: This rule is effective October 29, 2009

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.’’ The guidance provides information for seafood processors and other entities that are interested in obtaining export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). FDA is also announcing that it intends to stop issuing EU Export Certificates after February 17, 2009.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Voluntary Third-Party Certification Programs for Foods and Feeds.’’ This guidance describes the general attributes FDA believes a voluntary third-party certification program should have in order to help ensure its certification is a reliable reflection that the foods and feeds (hereinafter foods) from certified establishments meet applicable FDA requirements, as well as other certification criteria.

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ‘‘Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements,’’ that was issued December 1999.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ‘‘Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.’’ The revised guidance only changes the date on which FDA intends to stop issuing export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). The date FDA now intends to stop issuing EU Export Certificates is June 17, 2009

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Guidance for Industry:Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient.’’ This guidance is intended to clarify for manufacturers who produce foods containing a peanutderived product as an ingredient that there is a risk that Salmonella species may be present in the incoming peanutderived product, and to recommend measures to address that risk

The Food and Drug Administration (FDA) is confirming the effective date of January 5, 2011, for the final rule that appeared in the Federal Register of January 5, 2009. The final rule amends the regulations for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carminecontaining food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This action also responds to a citizen petition submitted by the Center for Science in the Public Interest.

Effective Date: The effective date of the final rule published on January 5, 2009

This rule is effective March 16, 2009. Submit written or electronic objections and requests for a hearing by April 15, 2009. See section VII of this document for information on filing objections. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of March 16, 2009.

Effective Date:This rule is effective March 16,2009

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of an aqueous solution of silver nitrate and hydrogen peroxide as an antimicrobial agent in bottled water. This action is in response to a petition filed by Kareem I. Batarseh

The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2009, for the final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ‘‘Substances Prohibited From Use in Animal Food or Feed.’’ The agency is also establishing a compliance date of October 26, 2009, for this rule in order to allow additional time for renderers to comply with the new requirements. This additional time will also give other affected persons, including cattle producers and packers, more time to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule.

Effective Date: The effective date of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720), is April 27, 2009.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #195 entitled ‘‘Small Entities Compliance Guide for Renderers— Substances Prohibited From Use in Animal Food or Feed’’ This small entities compliance guide aids renderers in complying with the requirements of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720). FDA’s goal is to strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle and to reduce the risk of human exposure to the BSE agent.

The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ‘‘Substances Prohibited From Use in Animal Food or Feed.’’ In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ‘‘Background’’ section. This document corrects that error .

Effective Date: This correction is effective: May 5 2009