TITLE: SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products; Agency Information Collection Activities; Proposed Collection ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Comment request ; ; SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products. ; ; DATES: Submit either electronic or written comments on the collection of information by 16 August 2011. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/html/2011-14771.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14771.pdf ;
Distribution date: 29 June 2011
Products Covered: Lip make-up preparations (HS code(s): 330410); Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), incl. sunscreen or sun tan preparations (excl. medicaments, lip and eye make-up preparations, manicure or pedicure preparations and make-up or skin care powders, incl. baby powders) (HS code(s): 330499)
Regulation Type: Revision to Regular Notification
TITLE: SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products; Agency Information Collection Activities; Proposed Collection ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Comment request ; ; SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products. ; ; DATES: Submit either electronic or written comments on the collection of information by 16 August 2011. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/html/2011-14771.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14771.pdf ;
Distribution date: 29 June 2011
Products Covered: Lip make-up preparations (HS code(s): 330410); Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), incl. sunscreen or sun tan preparations (excl. medicaments, lip and eye make-up preparations, manicure or pedicure preparations and make-up or skin care powders, incl. baby powders) (HS code(s): 330499)
Regulation Type: Revision to Regular Notification
TITLE: Labeling and Effectiveness Testing; Sunscreen Drug Products for ; Over-the-Counter Human Use ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Final Rule ; ; SUMMARY: The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of 27 August 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of 17 March 1999, by lifting the delay of implementation date for that rule that we published on 3 September 2004). ; ; DATES: Effective Date: This final rule is effective 18 June 2012. For additional information concerning this effective date, see section X in the preamble of this document. The incorporation by reference of a certain publication listed in this rule is approved by the Director of the Federal Register as of 18 June 2012. ; Compliance Date: The compliance date for all products subject to this final rule with annual sales less than $25,000 is 17 June 2013. ; The compliance date for all other products subject to this final rule is 18 June 2012. ; Implementation date: FDA is lifting the delay of implementation date for Sec. 201.66 as published at 69 FR 53801, 3 September 2004. ; ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/html/2011-14766.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf ; ;
Distribution date: 29 June 2011
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Labeling and Effectiveness Testing; Sunscreen Drug Products for ; Over-the-Counter Human Use ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Final Rule ; ; SUMMARY: The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of 27 August 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of 17 March 1999, by lifting the delay of implementation date for that rule that we published on 3 September 2004). ; ; DATES: Effective Date: This final rule is effective 18 June 2012. For additional information concerning this effective date, see section X in the preamble of this document. The incorporation by reference of a certain publication listed in this rule is approved by the Director of the Federal Register as of 18 June 2012. ; Compliance Date: The compliance date for all products subject to this final rule with annual sales less than $25,000 is 17 June 2013. ; The compliance date for all other products subject to this final rule is 18 June 2012. ; Implementation date: FDA is lifting the delay of implementation date for Sec. 201.66 as published at 69 FR 53801, 3 September 2004. ; ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/html/2011-14766.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf ; ;
Distribution date: 29 June 2011
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
Costa Rican Technical Regulation (RTCR) No. 449:2010: Technical Regulation on the labelling of fresh, frozen and defrosted fishery and aquaculture products and by-products sold in bulk or pre-packaged at the point of sale
Distribution date: 29 June 2011 | Final date for Comment: 20 July 2011
The text of notification G/SPS/N/CRI/110 is available online at: http://members.wto.org/crnattachments/2011/sps/CRI/11_1241_00_s.pdfThe aim of the notified Technical Regulation is to establish the basic requirements concerning the information to be included on the labels of fresh, frozen and defrosted fishery and aquaculture products and by-products sold in bulk or pre-packaged at the point of sale. The Regulation also includes provisions on residues of veterinary drugs and chemical contaminants, food additives and permitted microbiological criteria, and methods of analysis. It applies to both domestic and imported aquaculture products and by-products.
Products Covered:
Regulation Type: Addendum to Regular Notification
Costa Rican Technical Regulation (RTCR) No. 449:2010: Technical Regulation on the labelling of fresh, frozen and defrosted fishery and aquaculture products and by-products sold in bulk or pre-packaged at the point of sale
Distribution date: 29 June 2011 | Final date for Comment: 20 July 2011
The text of notification G/SPS/N/CRI/110 is available online at: http://members.wto.org/crnattachments/2011/sps/CRI/11_1241_00_s.pdfThe aim of the notified Technical Regulation is to establish the basic requirements concerning the information to be included on the labels of fresh, frozen and defrosted fishery and aquaculture products and by-products sold in bulk or pre-packaged at the point of sale. The Regulation also includes provisions on residues of veterinary drugs and chemical contaminants, food additives and permitted microbiological criteria, and methods of analysis. It applies to both domestic and imported aquaculture products and by-products.
Products Covered:
Regulation Type: Addendum to Regular Notification
Draft Supreme Decree approving the regulations governing the labelling of genetically modified foods (7 pages, in Spanish)
Distribution date: 27 June 2011 | Final date for Comment: 26 August 2011
The aim of the notified regulations is to establish the rules governing the labelling of packaged genetically modified foods, both domestic and imported, available to the consumer at points of final sale in the national territory, pursuant to Article 37 of Law No. 29571, the Consumer Protection and Defence Code.
Products Covered: 1108.12.00.00: Maize (corn) starch. 1201.00.90.00: Soya beans, whether or not broken, other than for sowing. 1205.10.90.00: Low erucic acid rape or colza seeds, other than for sowing. 1205.90.90.00: Rape or colza seeds, whether or not broken, other than for sowing. 1207.20.90.00: Cotton seeds, whether or not broken, other than for sowing. 1208.10.00.00: Flours and meals of soya beans. 1209.10.00.00: Sugar beet seed. 1212.91.00.00: Sugar beet. 1214.90.00.00: Swedes, mangolds, fodder roots, hay, clover, sainfoin, forage kale, lupines, vetches and similar forage products, whether or not in the form of pellets. 1302.19.20.00: Soya bean extract, whether or not in powder. 1507.10.00.00: Crude soya bean oil, whether or not degummed. 1507.90.10.00: Refined soya bean oil, containing added denaturalizing substances not exceeding 1 per cent. 1507.90.90.00: Soya bean oil, refined, other than containing added denaturalizing substances not exceeding 1 per cent. 1512.21.00.00: Crude cotton seed oil, whether or not gossypol has been removed. 1512.29.00.00: Other cotton seed oil, other than crude, whether or not gossypol has been removed. 1514.11.00.00: Low erucic acid rape or colza oil, crude. 1514.19.00.00: Other low erucic acid rape or colza oil, other than crude. 1515.21.00.00: Maize (corn) oil, crude. 1515.29.00.00: Maize (corn) oil, other than crude. 1701.12.00.00: Raw beet sugar not containing added flavouring or colouring matter. 1701.91.00.00: Refined cane or beet sugar and chemically pure sucrose, in solid form, containing added flavouring or colouring matter. 1701.99.90.00: Other cane or beet sugar, in solid form. 2005.80.00.00: Sweet corn (Zea mays var. saccharata) prepared or preserved otherwise than by vinegar or acetic acid, not frozen. 2103.10.00.00: Soya sauce. 2106.10.11.00: Soya protein concentrate, containing 65 per cent to 75 per cent protein on a dry basis. 3203.00.16.00: Colouring matter of purple maize/corn (anthocyanin)
Regulation Type: Regular notification
Draft Supreme Decree approving the regulations governing the labelling of genetically modified foods (7 pages, in Spanish)
Distribution date: 27 June 2011 | Final date for Comment: 26 August 2011
The aim of the notified regulations is to establish the rules governing the labelling of packaged genetically modified foods, both domestic and imported, available to the consumer at points of final sale in the national territory, pursuant to Article 37 of Law No. 29571, the Consumer Protection and Defence Code.
Products Covered: 1108.12.00.00: Maize (corn) starch. 1201.00.90.00: Soya beans, whether or not broken, other than for sowing. 1205.10.90.00: Low erucic acid rape or colza seeds, other than for sowing. 1205.90.90.00: Rape or colza seeds, whether or not broken, other than for sowing. 1207.20.90.00: Cotton seeds, whether or not broken, other than for sowing. 1208.10.00.00: Flours and meals of soya beans. 1209.10.00.00: Sugar beet seed. 1212.91.00.00: Sugar beet. 1214.90.00.00: Swedes, mangolds, fodder roots, hay, clover, sainfoin, forage kale, lupines, vetches and similar forage products, whether or not in the form of pellets. 1302.19.20.00: Soya bean extract, whether or not in powder. 1507.10.00.00: Crude soya bean oil, whether or not degummed. 1507.90.10.00: Refined soya bean oil, containing added denaturalizing substances not exceeding 1 per cent. 1507.90.90.00: Soya bean oil, refined, other than containing added denaturalizing substances not exceeding 1 per cent. 1512.21.00.00: Crude cotton seed oil, whether or not gossypol has been removed. 1512.29.00.00: Other cotton seed oil, other than crude, whether or not gossypol has been removed. 1514.11.00.00: Low erucic acid rape or colza oil, crude. 1514.19.00.00: Other low erucic acid rape or colza oil, other than crude. 1515.21.00.00: Maize (corn) oil, crude. 1515.29.00.00: Maize (corn) oil, other than crude. 1701.12.00.00: Raw beet sugar not containing added flavouring or colouring matter. 1701.91.00.00: Refined cane or beet sugar and chemically pure sucrose, in solid form, containing added flavouring or colouring matter. 1701.99.90.00: Other cane or beet sugar, in solid form. 2005.80.00.00: Sweet corn (Zea mays var. saccharata) prepared or preserved otherwise than by vinegar or acetic acid, not frozen. 2103.10.00.00: Soya sauce. 2106.10.11.00: Soya protein concentrate, containing 65 per cent to 75 per cent protein on a dry basis. 3203.00.16.00: Colouring matter of purple maize/corn (anthocyanin)
Regulation Type: Regular notification
Regulations regarding the fertilizers in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies (Act no 36 of 1947)
Distribution date: 27 June 2011 | Final date for Comment: 26 August 2011
SUB TOPICS ON REGULATIONS: Fertilizer Regulations intended for registration of fertilizer products intended for sale in the Republic of South Africa involves definitions, requirements for fertilizers, applications for registration, import permits and advertisements, labelling, payments, requirements for manufacturing plants and records to be kept as well as taking samples and analysis
Products Covered: Fertilizers ; HS: 31 ; CCCN: ; ICS : 65.080 ; National Tariff Heading: Fertilizers ;
Regulation Type: Regular notification
Regulations regarding the fertilizers in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies (Act no 36 of 1947)
Distribution date: 27 June 2011 | Final date for Comment: 26 August 2011
SUB TOPICS ON REGULATIONS: Fertilizer Regulations intended for registration of fertilizer products intended for sale in the Republic of South Africa involves definitions, requirements for fertilizers, applications for registration, import permits and advertisements, labelling, payments, requirements for manufacturing plants and records to be kept as well as taking samples and analysis
Products Covered: Fertilizers ; HS: 31 ; CCCN: ; ICS : 65.080 ; National Tariff Heading: Fertilizers ;
Regulation Type: Regular notification
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