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 | Final date for Comment: 15 May 2025
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum 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 | Final date for Comment: 15 May 2025
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 | Final date for Comment: 15 May 2025
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
Amendments to Sterility Test Requirements for Biological Products
Distribution date: 29 June 2011 | Final date for Comment: 28 August 2011
The Food and Drug Administration (FDA) proposes to amend the ; sterility test requirements for biological products. This proposed rule ; is intended to provide manufacturers of biological products greater ; flexibility and to encourage use of the most appropriate and state-of- ; the-art test methods for assuring the safety of biological products. We ; are taking this action as part of our continuing effort to review and, ; as necessary, update the biologics regulations. ;
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Regular notification
Amendments to Sterility Test Requirements for Biological Products
Distribution date: 29 June 2011 | Final date for Comment: 28 August 2011
The Food and Drug Administration (FDA) proposes to amend the ; sterility test requirements for biological products. This proposed rule ; is intended to provide manufacturers of biological products greater ; flexibility and to encourage use of the most appropriate and state-of- ; the-art test methods for assuring the safety of biological products. We ; are taking this action as part of our continuing effort to review and, ; as necessary, update the biologics regulations. ;
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Regular notification
CooperVision, Inc.; Filing of Color Additive Petition
Distribution date: 06 July 2011 | Final date for Comment: 15 May 2025
The Food and Drug Administration (FDA) is announcing that CooperVision, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of 1,4-bis[4-(2-methacryloxyethyl) phenlyamino]anthraquinone (C.I. Reactive Blue 246). The color additive is intended to be copolymerized with various monomers for use as a colored contact lens material. ; (Please comment to Docket No. FDA-2011-C-0344.) ;
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Regular notification
CooperVision, Inc.; Filing of Color Additive Petition
Distribution date: 06 July 2011 | Final date for Comment: 15 May 2025
The Food and Drug Administration (FDA) is announcing that CooperVision, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of 1,4-bis[4-(2-methacryloxyethyl) phenlyamino]anthraquinone (C.I. Reactive Blue 246). The color additive is intended to be copolymerized with various monomers for use as a colored contact lens material. ; (Please comment to Docket No. FDA-2011-C-0344.) ;
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Regular notification
CooperVision, Inc.; Filing of Color Additive Petition
Distribution date: 06 July 2011 | Final date for Comment: 15 May 2025
The Food and Drug Administration (FDA) is announcing that CooperVision, Inc. has filed a petition proposing that the color additive regulations be amended to provide for the safe us of 1,4-bis[2-hydroxyethyl]amino]-9, 10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color additive is intended to be copolymerized with various monomers for use as colored contact lens materials. ; ; (Please comment to Docket No. FDA-2011-C-0463) ;
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Regular notification
CooperVision, Inc.; Filing of Color Additive Petition
Distribution date: 06 July 2011 | Final date for Comment: 15 May 2025
The Food and Drug Administration (FDA) is announcing that CooperVision, Inc. has filed a petition proposing that the color additive regulations be amended to provide for the safe us of 1,4-bis[2-hydroxyethyl]amino]-9, 10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color additive is intended to be copolymerized with various monomers for use as colored contact lens materials. ; ; (Please comment to Docket No. FDA-2011-C-0463) ;
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Regular notification
Commission Regulation (EU) No 284/2011 of 22 March 2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People's Republic of China and Hong Kong Special Administrative Region, China [OJ L 77, 23 March 2011, p. 25-29]
Distribution date: 07 July 2011 | Final date for Comment: 15 May 2025
Several notifications and alerts have been received by the Rapid Alert System for Food and Feed concerning food contact materials imported into the Union from the People's Republic of China and Hong Kong Special Administrative Region of the People's Republic of China, releasing into food or food simulant amounts of chemicals that are not in compliance with the Union legislation. Article 48(2) of Regulation (EC) No 882/2004 provides for the possibility to impose specific import conditions on particular products coming from certain third countries, taking into account the risks associated with these products. This Regulation applies from 1 July 2011. The provisions of this Regulation should be periodically reviewed, taking into account the information received from the Member States.
Products Covered: Kitchenware of polyamide and of melamine consigned from China or Hong Kong, China (TARIC Code 3924.10.00.11); ICS Code: 97.190.
Regulation Type: Regular notification
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