Distribution date: 21 May 1999 | Final date for Comment: 25 April 2025

The Food and Drug Administration (FDA) is proposing to amend its regulations pertaining to the registration of foreign establishments and the listing of human drugs, animal drugs (including animal feed bearing or containing an animal drug for non-investigational uses), biological products (will not affect veterinary biologics as they are regulated by USDA), and devices. The proposal would require foreign establishments whose products are imported or offered for import into the United States to register with FDA. The proposal would also require foreign establishments to identify a United States agent and would describe some of the agent's responsibilities. The Agency is proposing these changes to implement section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) as it pertains to foreign establishment registration.

Products Covered: Animal drugs, human drugs, biological products, and devices

Regulation Type: Regular notification

Distribution date: 28 May 1999 | Final date for Comment: 25 April 2025

The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to allow the use of soy protein concentrate, both singly and in combination with modified food starch or carrageenan, as a binder in cured pork products labelled "Ham with Natural Juices", "Ham Water Added", and "Ham and Water Product -- X% of Weight is Added Ingredients", and to increase the permitted use level of modified food starch as a binder in "Ham and Water Product -- X% of Weight is Added Ingredients" products. These binders will be used to reduce purging of the pumped brine solution from the products. FSIS is proceeding with this direct final rule in response to petitions submitted by Central Soya and the National Starch and Chemical Company and informal requests from several food manufacturers.

Products Covered: Ham

Regulation Type: Regular notification

Distribution date: 14 July 1999 | Final date for Comment: 25 April 2025

The Food and Drug Administration (FDA) has determined that certain new animal drugs, vital to animal health, should be approved for use in animal feed, but only if such medicated feeds are administered under a veterinarian's order and supervision. This limitation is important for a number of reasons. For example, control of the usage of certain antimicrobials is critical to reducing unnecessary use of such drugs in animals and to slowing or preventing the development of bacterial resistance to antimicrobial drugs. FDA is proposing to amend the animal drug regulations to implement the Veterinary Feed Directive (VFD) drugs section of the animal Drug Availability Act (ADAA). A VFD drug is intended for use in animal feeds, and such use of the VFD drug is permitted only under the professional supervision of a licensed veterinarian. The proposed regulation would establish the requirements relating to the distribution and use of VFD drugs and animal feeds containing VFD drugs.

Products Covered: Animal drugs

Regulation Type: Regular notification

Distribution date: 29 July 1999 | Final date for Comment: 25 April 2025

The Food and Drug Administration (FDA) is proposing to amend its regulations to reclassify sheep as a minor species for all data collection purposes. This would allow sponsors of supplemental new animal drug applications (NADA's) to extrapolate human food safety data from a major species such as cattle to sheep. In particular, this will allow the extrapolation of the tolerances for residues of new animal drugs in cattle to sheep.

Products Covered: Animal drugs

Regulation Type: Regular notification

Distribution date: 29 July 1999 | Final date for Comment: 25 April 2025

The Food and Drug Administration (FDA) is announcing the availability for comment of three draft guidance documents developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. Document 1 provides guidance recommendations for applications for marketing authorizations on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesized new active substances not previously registered in a member state. Document 2 is an annex to the parent guidance VICH GL3 entitled "Stability Testing of New Drug Substances and Products in the Veterinary Field". This draft guidance document is the annex and addresses of the recommendations for stability testing of veterinary medicinal Type A medicated articles (referred to as medicated premix drug products in the draft guidance) intended for submission for approval to the European Communities, Japan, and the United States. Document 3 is draft guidance for industry entitled "Impurities in New Veterinary Drug Substances" and is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Communities, Japan and the United States

Products Covered: Veterinary medicinal products

Regulation Type: Regular notification

Distribution date: 30 August 1999 | Final date for Comment: 25 April 2025

Products Covered: This Agreement applies to products traded between Switzerland and Canada as well as to procedures which are subject to specified legislative, regulatory and administrative provisions pertaining to conformity assessment and technical regulations, as detailed in five sectoral annexes to the Agreement, in the areas of: Telecommunications terminal equipment (ch. 85.17), Electromagnetic compatibility (EMC) & Electrical Safety (ch. 85, except 85.17), Good Manufacturing Practices (ch. 30) and Medical Devices (ch. 90.18, 90.19, 91.20, 91.21, 19.22).

Regulation Type: Article 10.7 (TBT)

Distribution date: 14 October 1999 | Final date for Comment: 25 April 2025

Products Covered: The Agreement covers several product categories, called "sectors". The sectors which are covered are: medicinal products good manufacturing practice inspection and batch certification (30, HS 2), machinery (84, HS 2), low voltage equipment (85, HS 2), telecommunications terminal equipment (8517, HS 4), electromagnetic compatibility (85, HS 2), medical devices (9018, HS 4), and pressure equipment.

Regulation Type: Article 10.7 (TBT)

Distribution date: 24 January 2001 | Final date for Comment: 25 April 2025

This document proposes technical modifications in two of the tests included in the standard on brake fluids, i.e., the evaporation test and the corrosion test. This document also requests comments concerning retention of the evaporation test. A committee of the Society of Automotive Engineers, which originally developed the test, recently voted to delete the test from its standard on brake fluid. While the administration has tentatively concluded that the test should remain in our standard, we are requesting comments on that issue.

Products Covered: Vehicle Brake Fluids (HS Chapter 3819) (ICS 75.120)

Regulation Type: Regular notification

Distribution date: 26 February 2001 | Final date for Comment: 25 April 2025

The Thai authority decided to remove Phenylpropanolamine (PPA) from all drug products as there is evidence that PPA may cause haemorrhage stroke (bleeding into the brain). This order prescribes as follows: 1. Phenylpropanolamine (PPA) or their salts or those written otherwise but which are equivalent to PPA or their salts, must be removed from all drug products. 2. Producers or importers must apply for licences before 17 June 2001.

Products Covered: Medicaments HS Chapter 30.04, (ICS:  11.120.10)

Regulation Type: Regular notification

Distribution date: 04 April 2001 | Final date for Comment: 25 April 2025

Products Covered: Poisonous substance:  Narasin (HS:  29)

Regulation Type: Regular notification