TITLE: Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products AGENCY: Food and Drug Administration, HHS ACTION: Notice SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on sun protection factor (SPF) labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and comments on compliance with Drug Facts labeling requirements for all OTC sunscreen products. Submit either electronic or written comments on the collection of information by 22 October 2018.
Distribution date: 27 August 2018 | Final date for Comment: 28 April 2025
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Agency Information Collection Activities; Proposed Collection; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products AGENCY: Food and Drug Administration, HHS ACTION: Notice SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on sun protection factor (SPF) labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and comments on compliance with Drug Facts labeling requirements for all OTC sunscreen products. Submit either electronic or written comments on the collection of information by 22 October 2018.
Distribution date: 27 August 2018 | Final date for Comment: 28 April 2025
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
DUS 365: 2018, Powdered (icing) sugar — Specification, Second Edition.
Distribution date: 27 August 2018 | Final date for Comment: 26 October 2018
This Draft Uganda Standard specifies, requirements, method of test and sampling for white powdered (icing) sugar intended for use in toppings, icings and other sugar content bakery products.
Products Covered: Icing sugar
Regulation Type: Regular notification
DUS 365: 2018, Powdered (icing) sugar — Specification, Second Edition.
Distribution date: 27 August 2018 | Final date for Comment: 26 October 2018
This Draft Uganda Standard specifies, requirements, method of test and sampling for white powdered (icing) sugar intended for use in toppings, icings and other sugar content bakery products.
Products Covered: Icing sugar
Regulation Type: Regular notification
SI 2302 part 2 - Dangerous substances and mixtures: Transportation - Classification, labelling, marking and packaging
Distribution date: 28 August 2018 | Final date for Comment: 27 October 2018
Revision of the mandatory standard SI 2302 Part 2 dealing with the transportation of dangerous substances and mixtures. The major changes included in this draft standard revision are as follows: Removes from the standard's scope gas cylinders, that are covered by other mandatory standards; Uses the risk group symbols according to the UN document - Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Products Covered: Dangerous chemical substances and mixtures
Regulation Type: Regular notification
SI 2302 part 2 - Dangerous substances and mixtures: Transportation - Classification, labelling, marking and packaging
Distribution date: 28 August 2018 | Final date for Comment: 27 October 2018
Revision of the mandatory standard SI 2302 Part 2 dealing with the transportation of dangerous substances and mixtures. The major changes included in this draft standard revision are as follows: Removes from the standard's scope gas cylinders, that are covered by other mandatory standards; Uses the risk group symbols according to the UN document - Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Products Covered: Dangerous chemical substances and mixtures
Regulation Type: Regular notification
SI 2302 part 1 - Dangerous substances and mixtures: Classification, labelling, marking and packaging
Distribution date: 28 August 2018 | Final date for Comment: 27 October 2018
The draft revision of the Mandatory Standard SI 2302 Part 1, notified in G/TBT/N/ISR/726 (dated 3 December 2013) has been amended and replaced. The new draft revision is based, with a few changes and national deviations on the European Regulation (EC) No 1272/2008, which is based on the UN document "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)". The major changes included in this draft revision are as follows: Replaces the R-phrases (risk phrases) and S-phrases (safety phrases) with Hazard Statements (H) and with precautionary statements (P); Deletes the separate requirements for dangerous substances for domestic or similar uses and for non-domestic use. Both the old standard and the new revised standard will apply for a period of 3 years from the entry into force of this revision. During this period dangerous substances and mixtures for domestic and similar uses could be tested according to the old or the new revised standard.
Products Covered: Dangerous chemical substances and mixtures
Regulation Type: Revision to Regular Notification
SI 2302 part 1 - Dangerous substances and mixtures: Classification, labelling, marking and packaging
Distribution date: 28 August 2018 | Final date for Comment: 27 October 2018
The draft revision of the Mandatory Standard SI 2302 Part 1, notified in G/TBT/N/ISR/726 (dated 3 December 2013) has been amended and replaced. The new draft revision is based, with a few changes and national deviations on the European Regulation (EC) No 1272/2008, which is based on the UN document "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)". The major changes included in this draft revision are as follows: Replaces the R-phrases (risk phrases) and S-phrases (safety phrases) with Hazard Statements (H) and with precautionary statements (P); Deletes the separate requirements for dangerous substances for domestic or similar uses and for non-domestic use. Both the old standard and the new revised standard will apply for a period of 3 years from the entry into force of this revision. During this period dangerous substances and mixtures for domestic and similar uses could be tested according to the old or the new revised standard.
Products Covered: Dangerous chemical substances and mixtures
Regulation Type: Revision to Regular Notification
Proyecto de Reglamento Técnico para la Gestión Sanitaria y Ambiental de los Bifenilos Policlorados (Draft Technical Regulation for the health and environmental management of polychlorinated biphenyls) (21 pages, in Spanish)
Distribution date: 28 August 2018 | Final date for Comment: 23 October 2018
The notified Technical Regulation establishes the conditions necessary for the health and environmental management of stockpiles and residues of polychlorinated biphenyls (PCBs), and stockpiles and residues containing or contaminated with polychlorinated biphenyls (PCBs), with the aim of protecting human health and promoting environmental quality. It contains measures to prevent the contamination of the environment with PCBs and, therefore, avoid risks to human health. It also contains several of the articles established in the Stockholm Convention on Persistent Organic Pollutants (ratified by Peru in Supreme Decree No. 067-2005-RE).
Products Covered: Subheading Description 2710.19.33.00 Electrical insulation oils 2710.91.00.00 Waste oils containing polychlorinated biphenyls (PCBs) 3824.82.00.00 Mixtures and preparations containing polychlorinated biphenyls (PCBs) 8504.21.19.00 Liquid dielectric transformers, having a power handling capacity not exceeding 10 kVA 8504.21.90.00 Liquid dielectric transformers, having a power handling capacity above 10 kVA but not exceeding 650 kVA 8504.22.10.00 Liquid dielectric transformers, having a power handling capacity above 650 kVA but not exceeding 1000 kVA 8504.22.90.00 Liquid dielectric transformers, having a power handling capacity above 1000 kVA but not exceeding 10,000 kVA 8504.23.00.00 Liquid dielectric transformers, having a power handling capacity above 10,000 kVA 8532.10.00.00 Fixed capacitors designed for use in 50/60 Hz circuits and having a reactive power handling capacity of not less than 0.5 kvar (power capacitors) 3824.81.00.00 Mixtures and preparations containing oxirane (ethylene oxide) 3824.82.00.00 Mixtures and preparations containing polybrominated biphenyls (PBBs), polychlorinated biphenyls (PCBs) or polychlorinated terphenyls (PCTs) 3824.83.00.00 Mixtures and preparations containing tris (2,3-dibromopropyl) phosphate 3822.00.30.00 Certified reference materials
Regulation Type: Regular notification
Proyecto de Reglamento Técnico para la Gestión Sanitaria y Ambiental de los Bifenilos Policlorados (Draft Technical Regulation for the health and environmental management of polychlorinated biphenyls) (21 pages, in Spanish)
Distribution date: 28 August 2018 | Final date for Comment: 23 October 2018
The notified Technical Regulation establishes the conditions necessary for the health and environmental management of stockpiles and residues of polychlorinated biphenyls (PCBs), and stockpiles and residues containing or contaminated with polychlorinated biphenyls (PCBs), with the aim of protecting human health and promoting environmental quality. It contains measures to prevent the contamination of the environment with PCBs and, therefore, avoid risks to human health. It also contains several of the articles established in the Stockholm Convention on Persistent Organic Pollutants (ratified by Peru in Supreme Decree No. 067-2005-RE).
Products Covered: Subheading Description 2710.19.33.00 Electrical insulation oils 2710.91.00.00 Waste oils containing polychlorinated biphenyls (PCBs) 3824.82.00.00 Mixtures and preparations containing polychlorinated biphenyls (PCBs) 8504.21.19.00 Liquid dielectric transformers, having a power handling capacity not exceeding 10 kVA 8504.21.90.00 Liquid dielectric transformers, having a power handling capacity above 10 kVA but not exceeding 650 kVA 8504.22.10.00 Liquid dielectric transformers, having a power handling capacity above 650 kVA but not exceeding 1000 kVA 8504.22.90.00 Liquid dielectric transformers, having a power handling capacity above 1000 kVA but not exceeding 10,000 kVA 8504.23.00.00 Liquid dielectric transformers, having a power handling capacity above 10,000 kVA 8532.10.00.00 Fixed capacitors designed for use in 50/60 Hz circuits and having a reactive power handling capacity of not less than 0.5 kvar (power capacitors) 3824.81.00.00 Mixtures and preparations containing oxirane (ethylene oxide) 3824.82.00.00 Mixtures and preparations containing polybrominated biphenyls (PBBs), polychlorinated biphenyls (PCBs) or polychlorinated terphenyls (PCTs) 3824.83.00.00 Mixtures and preparations containing tris (2,3-dibromopropyl) phosphate 3822.00.30.00 Certified reference materials
Regulation Type: Regular notification
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