Regulatory Updates
TITLE: Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms; Extension of Comment Period ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Advance notice of proposed rulemaking; request for data and information; extension of comment period ; ; SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that published on 17 June 2011. The ANPRM is requesting data and information on certain dosage forms of over-the-counter (OTC) sunscreen drug products marketed without approved applications. The comment period for that ANPRM will end on 15 September 2011. This document extends the comment period to 17 October 2011. ; ; DATES: Submit either electronic or written data and information by 17 October 2011. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-14/html/2011-23479.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-14/pdf/2011-23479.pdf ; ;
Distribution date: 19 September 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: Addendum to Regular Notification
TITLE: Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms; Extension of Comment Period ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Advance notice of proposed rulemaking; request for data and information; extension of comment period ; ; SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that published on 17 June 2011. The ANPRM is requesting data and information on certain dosage forms of over-the-counter (OTC) sunscreen drug products marketed without approved applications. The comment period for that ANPRM will end on 15 September 2011. This document extends the comment period to 17 October 2011. ; ; DATES: Submit either electronic or written data and information by 17 October 2011. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-14/html/2011-23479.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-14/pdf/2011-23479.pdf ; ;
Distribution date: 19 September 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: Addendum to Regular Notification
TITLE: Natural health products ; AGENCY: New Zealand Ministry of Health, P O Box 5013, Wellington, New Zealand. Tel +64 496 2000; Fax +64 496 2191; website: www.moh.govt.nz ; Sally Stewart, Senior Policy Analyst ; Ministry of Health ; P O Box 5013, Wellington ; New Zealand ; Email: sally_stewart@moh.govt.nz ; Tel: +64 4 496 2000 ; Fax: +64 4 496 2191 ; Website: www.moh.govt.nz ; ACTION: Please delete the contents of Box 4 and replace with the following: ; ; Products covered (HS or CCCN where applicable, otherwise national tariff heading. ; ICS numbers may be provided in addition, where applicable): Natural health products where a therapeutic claim is made, including, but not restricted to, some products of HS classification 15.04, 1505.00, 15.15, 15.21, 2106.90, 29.36, 30.01, 3004.50, 33.01, 33.04, 33.05, 33.07, and 34.01. ;
Distribution date: 16 September 2011
Products Covered: Natural health products (11.120.10)
Regulation Type: Corrigendum to Regular Notification
TITLE: Natural health products ; AGENCY: New Zealand Ministry of Health, P O Box 5013, Wellington, New Zealand. Tel +64 496 2000; Fax +64 496 2191; website: www.moh.govt.nz ; Sally Stewart, Senior Policy Analyst ; Ministry of Health ; P O Box 5013, Wellington ; New Zealand ; Email: sally_stewart@moh.govt.nz ; Tel: +64 4 496 2000 ; Fax: +64 4 496 2191 ; Website: www.moh.govt.nz ; ACTION: Please delete the contents of Box 4 and replace with the following: ; ; Products covered (HS or CCCN where applicable, otherwise national tariff heading. ; ICS numbers may be provided in addition, where applicable): Natural health products where a therapeutic claim is made, including, but not restricted to, some products of HS classification 15.04, 1505.00, 15.15, 15.21, 2106.90, 29.36, 30.01, 3004.50, 33.01, 33.04, 33.05, 33.07, and 34.01. ;
Distribution date: 16 September 2011
Products Covered: Natural health products (11.120.10)
Regulation Type: Corrigendum to Regular Notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (revision of agricultural chemical residue standards)
Distribution date: 16 September 2011 | Final date for Comment: 15 November 2011
Proposed maximum residue limits (MRLs) for agricultural chemicals pesticides: Imazapic and Isoxaflutole.
Products Covered: Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce and birds' eggs (HS Codes: 04.01,04.07, and 04.08) Edible vegetables and certain roots and tubers (HS Codes: 07.09, 07.10, and 07.13) Peel of citrus/melons (HS Code: 08.14) Coffee, tea, mate and spices (HS Codes: 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.05 and 12.12) Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (revision of agricultural chemical residue standards)
Distribution date: 16 September 2011 | Final date for Comment: 15 November 2011
Proposed maximum residue limits (MRLs) for agricultural chemicals pesticides: Imazapic and Isoxaflutole.
Products Covered: Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce and birds' eggs (HS Codes: 04.01,04.07, and 04.08) Edible vegetables and certain roots and tubers (HS Codes: 07.09, 07.10, and 07.13) Peel of citrus/melons (HS Code: 08.14) Coffee, tea, mate and spices (HS Codes: 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.05 and 12.12) Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)
Regulation Type: Regular notification
TITLE: CooperVision, Inc.; Filing of Color Additive Petitions ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Correction ; ; SUMMARY: In proposed rule document C1-2011-16089 appearing on page 49707 in the issue of Thursday, 11 August 2011, make the following correction: ; On page 49707, in the first column, in the nineteenth line, methacryloxyethyl)phenlyamino] should read methacryloxyethyl)phenylamino]. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-07/html/C2-2011-16089.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-07/pdf/C2-2011-16089.pdf ; ;
Distribution date: 14 September 2011
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Corrigendum to Regular Notification
TITLE: CooperVision, Inc.; Filing of Color Additive Petitions ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Correction ; ; SUMMARY: In proposed rule document C1-2011-16089 appearing on page 49707 in the issue of Thursday, 11 August 2011, make the following correction: ; On page 49707, in the first column, in the nineteenth line, methacryloxyethyl)phenlyamino] should read methacryloxyethyl)phenylamino]. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-07/html/C2-2011-16089.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-09-07/pdf/C2-2011-16089.pdf ; ;
Distribution date: 14 September 2011
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Corrigendum to Regular Notification
TITLE: CooperVision, Inc.; Filing of Color Additive Petitions ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Correction ; ; SUMMARY: This corrigendum is to inform that in the notification G/TBT/N/USA/638, Products covered should read as: Contact lenses (Colour Additives) (HS 9001.30; ICS 11.040, 71.100). ;
Distribution date: 14 September 2011
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Corrigendum to Regular Notification
TITLE: CooperVision, Inc.; Filing of Color Additive Petitions ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Correction ; ; SUMMARY: This corrigendum is to inform that in the notification G/TBT/N/USA/638, Products covered should read as: Contact lenses (Colour Additives) (HS 9001.30; ICS 11.040, 71.100). ;
Distribution date: 14 September 2011
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Corrigendum to Regular Notification
Submit your email ID to receive notifications about upcoming courses and events