Distribution date: 11 April 2023 | Final date for Comment: 18 May 2023

The Food and Drug Administration (FDA or we) is extending the comment period for the color additive petition for which we published a notice of filing in the Federal Register of 17 February 2023. In the notice, FDA requested comments on a filed color additive petition submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 

Products Covered: Inorganic or mineral colouring matter, n.e.s.; preparations based on inorganic or mineral colouring matter of a kind used for colouring any material or produce colorant preparations (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215); inorganic products of a kind used as luminophores, whether or not chemically defined (HS code(s): 3206); Food technology (ICS code(s): 67)

Regulation Type: Addendum to Regular Notification

Distribution date: 11 April 2023 | Final date for Comment: 10 June 2023

This Draft East African Standard specifies general requirements, sampling and test methods for garments, whether made of textile, plastic-coated fabric, fur or any combination of these materials. This draft standard does not apply to personal protective wear.NOTE: Where provisions are specified in the specific parts of DEAS 1141 or any other relevant East African Standard, these shall supersede the requirements in this Draft East African Standard.

Products Covered: ARTICLES OF APPAREL AND CLOTHING ACCESSORIES, NOT KNITTED OR CROCHETED (HS code(s): 62); Clothes (ICS code(s): 61.020)

Regulation Type: Regular notification

Distribution date: 11 April 2023 | Final date for Comment: 10 June 2023

This Draft East African Standard specifies general requirements, sampling and test methods for garments, whether made of textile, plastic-coated fabric, fur or any combination of these materials. This draft standard does not apply to personal protective wear.NOTE: Where provisions are specified in the specific parts of DEAS 1141 or any other relevant East African Standard, these shall supersede the requirements in this Draft East African Standard.

Products Covered: ARTICLES OF APPAREL AND CLOTHING ACCESSORIES, NOT KNITTED OR CROCHETED (HS code(s): 62); Clothes (ICS code(s): 61.020)

Regulation Type: Regular notification

Distribution date: 11 April 2023 | Final date for Comment: 10 June 2023

This Draft East African Standard specifies general requirements, sampling and test methods for garments, whether made of textile, plastic-coated fabric, fur or any combination of these materials. This draft standard does not apply to personal protective wear.NOTE: Where provisions are specified in the specific parts of DEAS 1141 or any other relevant East African Standard, these shall supersede the requirements in this Draft East African Standard.

Products Covered: ARTICLES OF APPAREL AND CLOTHING ACCESSORIES, NOT KNITTED OR CROCHETED (HS code(s): 62); Clothes (ICS code(s): 61.020)

Regulation Type: Regular notification

Distribution date: 11 April 2023 | Final date for Comment: 10 June 2023

This Draft East African Standard specifies general requirements, sampling and test methods for garments, whether made of textile, plastic-coated fabric, fur or any combination of these materials. This draft standard does not apply to personal protective wear.NOTE: Where provisions are specified in the specific parts of DEAS 1141 or any other relevant East African Standard, these shall supersede the requirements in this Draft East African Standard.

Products Covered: ARTICLES OF APPAREL AND CLOTHING ACCESSORIES, NOT KNITTED OR CROCHETED (HS code(s): 62); Clothes (ICS code(s): 61.020)

Regulation Type: Regular notification

Distribution date: 11 April 2023 | Final date for Comment: 10 June 2023

This Draft East African Standard specifies general requirements, sampling and test methods for garments, whether made of textile, plastic-coated fabric, fur or any combination of these materials. This draft standard does not apply to personal protective wear.NOTE: Where provisions are specified in the specific parts of DEAS 1141 or any other relevant East African Standard, these shall supersede the requirements in this Draft East African Standard.

Products Covered: ARTICLES OF APPAREL AND CLOTHING ACCESSORIES, NOT KNITTED OR CROCHETED (HS code(s): 62); Clothes (ICS code(s): 61.020)

Regulation Type: Regular notification

Distribution date: 06 April 2023 | Final date for Comment: 06 May 2023

The Minimum Requirements for Biological Products will be partially amended. A vaccine product to be newly approved: “Recombinant Coronavirus (SARS-CoV-2) Vaccine”  The Public Notice on National Release Testing will be partially amended. The fee, criterion and quantity for National Release Testing of the following vaccine will be amended: “Freeze-dried Gas Gangrene Antitoxin, Equine”, “Recombinant Coronavirus (SARS-CoV-2) Vaccine”, “Freeze-dried Diphtheria Antitoxin, Equine”, “Freeze-dried Habu Antivenom, Equine”, “Freeze-dried Botulism Antitoxin, Equine”, “Freeze-dried Mamushi Antivenom, Equine”, “Human Plasma Protein Fraction”, “Human Serum Albumin”, “Freeze-dried Human Fibrinogen”, “Lyophilized Human Prothrombin Complex Concentrate”, “Freeze-dried Concentrated Blood Coagulation Factor VIII”, “Freeze-dried activated human blood coagulation factor VII concentrate containing factor X”, “Normal Human Immunoglobulin”, “Freeze-dried Ion-exchange-resin-treated Normal Human Immunoglobulin”, “Freeze-dried Sulfonated Normal Human Immunoglobulin”, “pH 4-treated Normal Human Immunoglobulin”, “pH4-Treated Normal Human Immunoglobulin （ Subcutaneous injection）”, “Freeze-dried pH 4-treated Normal Human Immunoglobulin”, “Freeze-dried Pepsin-treated Normal Human Immunoglobulin”, “Polyethylene Glycol-treated Normal Human Immunoglobulin”, “Freeze-dried Polyethylene Glycol-treated Normal Human Immunoglobulin “, “Human Anti-HBs Immunoglobulin”, “Freeze-dried Human Anti-HBs Immunoglobulin”, “Polyethylene Glycol-treated Human Anti-HBs Immunoglobulin”, “Human Anti-D(Rho) Immunoglobulin”, “Freeze-dried Human Anti-D(Rho) Immunoglobulin”, “Human Anti-tetanus Immunoglobulin”, “Freeze-dried Human Anti-tetanus Immunoglobulin”, “Polyethylene Glycol-treated Human Anti-tetanus Immunoglobulin”, “Freeze-dried Human Antithrombin III Concentrate”, “Freeze-dried Human Activated Protein C Concentrate”, and “Human Haptoglobin”.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 06 April 2023

Burundi, Kenya, Rwanda, Tanzania and Uganda would like to inform WTO Members that the Draft East African Standard; DEAS 876:2021, Skincare creams, lotions and gels — Specification, Second Edition; notified in G/TBT/N/BDI/196, G/TBT/N/KEN/1187, G/TBT/N/RWA/587, G/TBT/N/TZA/684, G/TBT/N/UGA/1526, G/TBT/N/BDI/196/Corr.1, G/TBT/N/KEN/1187/Corr.1, G/TBT/N/RWA/587/Corr.1, G/TBT/N/TZA/684/Corr.1 and G/TBT/N/UGA/1526/Corr.1 was adopted by the East African Community Council of Ministers on 24 February 2023.

Products Covered: Skincare creams, lotions, gels

Regulation Type: Addendum to Regular Notification

Distribution date: 06 April 2023

Burundi, Kenya, Rwanda, Tanzania and Uganda would like to inform WTO Members that the Draft East African Standard; DEAS 842-2:2021, Hair shampoo — Specification — Part 2: Synthetic detergent-based, Second Edition, notified in G/TBT/N/BDI/195, G/TBT/N/KEN/1176, G/TBT/N/RWA/586, G/TBT/N/TZA/683 and  G/TBT/N/UGA/1525 was adopted by the East African Community Council of Ministers on 24 February 2023.

Products Covered: Hair shampoo Synthetic detergent-based

Regulation Type: Addendum to Regular Notification

Distribution date: 06 April 2023

Burundi, Kenya, Rwanda, Tanzania and Uganda would like to inform WTO Members that the Draft East African Standard; DEAS 876:2021, Skincare creams, lotions and gels — Specification, Second Edition; notified in G/TBT/N/BDI/196, G/TBT/N/KEN/1187, G/TBT/N/RWA/587, G/TBT/N/TZA/684, G/TBT/N/UGA/1526, G/TBT/N/BDI/196/Corr.1, G/TBT/N/KEN/1187/Corr.1, G/TBT/N/RWA/587/Corr.1, G/TBT/N/TZA/684/Corr.1 and G/TBT/N/UGA/1526/Corr.1 was adopted by the East African Community Council of Ministers on 24 February 2023.

Products Covered: Skincare creams, lotions, gels

Regulation Type: Addendum to Regular Notification