Distribution date: 31 August 2006 | Final date for Comment: 22 April 2025

FDA issued proposed regulations to implement section 572 of the Federal Food Drug and Cosmetic Act entitled "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." These regulations propose administrative procedures and criteria for index listing a new animal drug for use in a minor animal species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor animal species in the United States.

Products Covered: Animal drugs

Regulation Type: Regular notification

Distribution date: 04 September 2006 | Final date for Comment: 22 April 2025

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.

Products Covered: Skin bleaching drug products (HS:  Chapter 3004;  ICS:  11)

Regulation Type: Regular notification

Distribution date: 04 September 2006 | Final date for Comment: 22 April 2025

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.

Products Covered: Skin bleaching drug products (HS:  Chapter 3004;  ICS:  11)

Regulation Type: Regular notification

Distribution date: 04 September 2006 | Final date for Comment: 22 April 2025

The Food and Drug Administration (FDA) is proposing to amend its regulations governing drug establishment registration and drug listing. The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products (including vaccines and allergenic products), and/or human cells, tissues, and cellular and tissue-based products (HCT/Ps), and animal drugs. The proposal describes when and how to register and list and what information must be submitted for registration and listing. In addition, the proposal would make certain changes to the National Drug Code (NDC) system and would require the appropriate NDC number to appear on the labels for drugs subject to the listing requirements. The proposed regulations generally would require the electronic submission of all registration and most listing information. We (FDA) rely on establishment registration and drug listing information for administering many of our programs, such as postmarketing surveillance (including FDA inspections), bioterrorism, drug shortages and availability, and user fee assessments. We are taking this action to use the latest technology to improve our registration and listing system, which would further our goal of protecting the public health. We also believe that the conversion to an electronic system would make the registration and listing processes more efficient and effective for industry and us. We are also taking this action to support the implementation of, for example, the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act, our rulemaking requiring a bar code on certain drug products, and the DailyMed initiative.

Products Covered: Human and animal drugs  (HS Chapter 3004;  ICS:  11.120, 11.220)

Regulation Type: Regular notification

Distribution date: 04 September 2006 | Final date for Comment: 22 April 2025

The Food and Drug Administration (FDA) is proposing to amend its regulations governing drug establishment registration and drug listing. The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products (including vaccines and allergenic products), and/or human cells, tissues, and cellular and tissue-based products (HCT/Ps), and animal drugs. The proposal describes when and how to register and list and what information must be submitted for registration and listing. In addition, the proposal would make certain changes to the National Drug Code (NDC) system and would require the appropriate NDC number to appear on the labels for drugs subject to the listing requirements. The proposed regulations generally would require the electronic submission of all registration and most listing information. We (FDA) rely on establishment registration and drug listing information for administering many of our programs, such as postmarketing surveillance (including FDA inspections), bioterrorism, drug shortages and availability, and user fee assessments. We are taking this action to use the latest technology to improve our registration and listing system, which would further our goal of protecting the public health. We also believe that the conversion to an electronic system would make the registration and listing processes more efficient and effective for industry and us. We are also taking this action to support the implementation of, for example, the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act, our rulemaking requiring a bar code on certain drug products, and the DailyMed initiative.

Products Covered: Human and animal drugs  (HS Chapter 3004;  ICS:  11.120, 11.220)

Regulation Type: Regular notification

Distribution date: 15 September 2006 | Final date for Comment: 22 April 2025

Advance Notice of Proposed Rulelmaking (ANPRM). OSHA, other Federal agencies, and stakeholder representatives have participated in long-term international negotiations to develop a Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The GHS has been adopted by the United Nations, and there is an international goal for as many countries as possible to implement the GHS by 2008. The GHS includes harmonized provisions for classification of chemicals for their health, physical, and environmental effects, as well as for labels on containers and safety data sheets (SDS). Adoption of the GHS by OSHA would require modifications to the Agency's Hazard Communication Standard (HCS). For example, an order of information would be established for safety data sheets. In this notice, OSHA is providing further information about the GHS, the benefits of adopting it, and its potential impact on the HCS. OSHA is seeking input from the public on a number of issues related to implementation of the GHS. The Agency is simultaneously announcing the availability of a new guide on its Web site at http://www.osha.gov/ that describes the GHS.

Products Covered: Chemicals (HS:  Chapter 29 ) (ICS:  13, 71)

Regulation Type: Regular notification

Distribution date: 15 September 2006 | Final date for Comment: 22 April 2025

Advance Notice of Proposed Rulelmaking (ANPRM). OSHA, other Federal agencies, and stakeholder representatives have participated in long-term international negotiations to develop a Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The GHS has been adopted by the United Nations, and there is an international goal for as many countries as possible to implement the GHS by 2008. The GHS includes harmonized provisions for classification of chemicals for their health, physical, and environmental effects, as well as for labels on containers and safety data sheets (SDS). Adoption of the GHS by OSHA would require modifications to the Agency's Hazard Communication Standard (HCS). For example, an order of information would be established for safety data sheets. In this notice, OSHA is providing further information about the GHS, the benefits of adopting it, and its potential impact on the HCS. OSHA is seeking input from the public on a number of issues related to implementation of the GHS. The Agency is simultaneously announcing the availability of a new guide on its Web site at http://www.osha.gov/ that describes the GHS.

Products Covered: Chemicals (HS:  Chapter 29 ) (ICS:  13, 71)

Regulation Type: Regular notification

Distribution date: 15 September 2006 | Final date for Comment: 22 April 2025

The draft regulation encompasses all situations associated with developing, producing, importing, processing, distributing, exporting and selling of products for external use for care and marking using chemical means of animals and animal health care personnel's duty to report any side effects when using such products. Products meant for use in the eyes or which are consumed orally are not included. Products which are fixed items are not included.

Products Covered: Product for external use for care and marking using chemical means of animals: Substance or combination of substances which is used for external care of animals for hygienic purposes or for reasons of welfare, appearance or protection, and substances which are injected in animals subcutaneously to mark them. External care also encompasses care of bodily orifices (mouth, teeth, etc).

Regulation Type: Regular notification

Distribution date: 15 September 2006 | Final date for Comment: 22 April 2025

The draft regulation encompasses all situations associated with developing, producing, importing, processing, distributing, exporting and selling of products for external use for care and marking using chemical means of animals and animal health care personnel's duty to report any side effects when using such products. Products meant for use in the eyes or which are consumed orally are not included. Products which are fixed items are not included.

Products Covered: Product for external use for care and marking using chemical means of animals: Substance or combination of substances which is used for external care of animals for hygienic purposes or for reasons of welfare, appearance or protection, and substances which are injected in animals subcutaneously to mark them. External care also encompasses care of bodily orifices (mouth, teeth, etc).

Regulation Type: Regular notification

Distribution date: 15 September 2006 | Final date for Comment: 22 April 2025

Products Covered: Liquid polyaluminium chloride (HS:  282732; ICS:  71.100.80)

Regulation Type: Regular notification