Regulatory Updates
CooperVision, Inc.; Filing of Color Additive Petition
Distribution date: 06 July 2011
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
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
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
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
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