TITLE: Labeling for Bronchodilators To Treat Asthma; Cold, Cough, ; Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- ; Counter Human Use ; ; AGENCY: Food and Drug Administration, HHS. ; ; ACTION: Final rule. ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the final ; monograph (FM) for over-the-counter (OTC) bronchodilator drug products ; to add additional warnings (e.g., an ``Asthma alert'') and to revise ; the indications, warnings, and directions in the labeling of products ; containing the ingredients ephedrine, ephedrine hydrochloride, ; ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine ; hydrochloride, and racepinephrine hydrochloride. FDA is issuing this ; final rule after considering data and information submitted in response ; to the Agency's proposed labeling revisions for these products. This ; final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; ; Effective Date: This regulation is effective 23 January 2012. ; ; Compliance Date: The compliance date for all products, regardless ; of annual sales, is 23 January 2012. ; ; FULL TEXT URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18347.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18347.pdf ;
Distribution date: 04 August 2011 | Final date for Comment: 14 May 2025
Products Covered: Human Drug Products (HS Chapter 30; ICS 11.120)
Regulation Type: Addendum to Regular Notification
Chemicals used for treatment of water intended for human consumption: Sodium chlorite (9 pages in Hebrew and 38 pages in English and French).
Distribution date: 11 August 2011 | Final date for Comment: 10 October 2011
Revision of the Mandatory Standard SI 5438 part 8. This draft standard revision adopts the European Standard EN 938: January 2009. The major differences between the old version and this new revised draft standard are detailed in page 3 of the European Standard (Foreword). In addition, here are the major changes that appear in the standard's Hebrew section: ; -Deletes from table 6 of paragraph 4.4 the requirements for type 2 sodium chlorite, leaving only one type. ; -Adds new sampling methods to paragraph 5.1.3 dealing with sampling from tanks and tankers. ; -Adds references to other international analysis methods in addition to the European method described in paragraph 5.2, as well as amending its formulas. ; -Adds to paragraph 6 dealing with labelling-transportation-storage a requirement to comply also with Israel Mandatory Standards SI 2032 parts 1 and 2. ; -Changes paragraph 6.4 dealing with marking by adding a requirement to mark in Hebrew and by adding a requirement to mark the concentration of sodium chlorite. ; ;
Products Covered: Chemicals used for treatment of water intended for human consumption (ICS: 71.100.80; HS: 2829.1011).
Regulation Type: Regular notification
Chemicals used for treatment of water intended for human consumption: Sodium chlorite (9 pages in Hebrew and 38 pages in English and French).
Distribution date: 11 August 2011 | Final date for Comment: 10 October 2011
Revision of the Mandatory Standard SI 5438 part 8. This draft standard revision adopts the European Standard EN 938: January 2009. The major differences between the old version and this new revised draft standard are detailed in page 3 of the European Standard (Foreword). In addition, here are the major changes that appear in the standard's Hebrew section: ; -Deletes from table 6 of paragraph 4.4 the requirements for type 2 sodium chlorite, leaving only one type. ; -Adds new sampling methods to paragraph 5.1.3 dealing with sampling from tanks and tankers. ; -Adds references to other international analysis methods in addition to the European method described in paragraph 5.2, as well as amending its formulas. ; -Adds to paragraph 6 dealing with labelling-transportation-storage a requirement to comply also with Israel Mandatory Standards SI 2032 parts 1 and 2. ; -Changes paragraph 6.4 dealing with marking by adding a requirement to mark in Hebrew and by adding a requirement to mark the concentration of sodium chlorite. ; ;
Products Covered: Chemicals used for treatment of water intended for human consumption (ICS: 71.100.80; HS: 2829.1011).
Regulation Type: Regular notification
Withdrawal of the Draft Order of the Ministry of Agrarian Policy and Food of Ukraine "On procedure for granting approval by the Chief State Inspection for the protection of plants of Ukraine for issuing licence to plant protection chemical means which are subject of import licensing in 2011"
Distribution date: 11 August 2011 | Final date for Comment: 14 May 2025
The Ministry of Agrarian Policy and Food of Ukraine withdrew the draft order "On procedure for granting approval by the Chief State Inspection for the protection of plants of Ukraine for issuing licence to plant protection chemical means which are subject of import licensing in 2011". At the same time, issuing approvals to plant protection chemical means which are subject of import licensing in 2011, under HS Codes 3808 10 (3808 91), 3808 20 (3808 92), 3808 30 (3808 93), 3808 90 (3808 99) is being carried out in accordance with the Resolution of the Cabinet of Ministers of Ukraine #1183 of 22 December 2010 which approves the list of imported goods which are subject to licensing, and quotas in 2011. In practice, this year the Ministry applies the same procedure for granting approval that was used in 2010.
Products Covered:
Regulation Type: Addendum to Regular Notification
Withdrawal of the Draft Order of the Ministry of Agrarian Policy and Food of Ukraine "On procedure for granting approval by the Chief State Inspection for the protection of plants of Ukraine for issuing licence to plant protection chemical means which are subject of import licensing in 2011"
Distribution date: 11 August 2011 | Final date for Comment: 14 May 2025
The Ministry of Agrarian Policy and Food of Ukraine withdrew the draft order "On procedure for granting approval by the Chief State Inspection for the protection of plants of Ukraine for issuing licence to plant protection chemical means which are subject of import licensing in 2011". At the same time, issuing approvals to plant protection chemical means which are subject of import licensing in 2011, under HS Codes 3808 10 (3808 91), 3808 20 (3808 92), 3808 30 (3808 93), 3808 90 (3808 99) is being carried out in accordance with the Resolution of the Cabinet of Ministers of Ukraine #1183 of 22 December 2010 which approves the list of imported goods which are subject to licensing, and quotas in 2011. In practice, this year the Ministry applies the same procedure for granting approval that was used in 2010.
Products Covered:
Regulation Type: Addendum to Regular Notification
DKS 2341:2011 ; Industrial Liquid Chlorine Specification (10 pages, in English) ;
Distribution date: 12 August 2011 | Final date for Comment: 13 September 2011
This standard prescribes the requirements and test methods for compressed Industrial Chlorine in the form of liquid.
Products Covered: Industrial Liquid Chlorine (HS 280110)
Regulation Type: Regular notification
DKS 2341:2011 ; Industrial Liquid Chlorine Specification (10 pages, in English) ;
Distribution date: 12 August 2011 | Final date for Comment: 13 September 2011
This standard prescribes the requirements and test methods for compressed Industrial Chlorine in the form of liquid.
Products Covered: Industrial Liquid Chlorine (HS 280110)
Regulation Type: Regular notification
Feed and food of non-animal origin
Distribution date: 17 August 2011 | Final date for Comment: 14 May 2025
The last revision of Commission Regulation (EC) No 669/2009 has been adopted as "Commission Implementing Regulation (EU) No 799/2011 of 9 August 2011 amending Annex I to Commission Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin" (OJ L 205, 10 August 2011, pp.15-21). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:205:0015:0021:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:205:0015:0021:FR:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:205:0015:0021:ES:PDF or http://members.wto.org/crnattachments/2011/sps/EEC//11_2727_00_e.pdf http://members.wto.org/crnattachments/2011/sps/EEC//11_2727_00_f.pdf http://members.wto.org/crnattachments/2011/sps/EEC//11_2727_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Feed and food of non-animal origin
Distribution date: 17 August 2011 | Final date for Comment: 14 May 2025
The last revision of Commission Regulation (EC) No 669/2009 has been adopted as "Commission Implementing Regulation (EU) No 799/2011 of 9 August 2011 amending Annex I to Commission Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin" (OJ L 205, 10 August 2011, pp.15-21). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:205:0015:0021:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:205:0015:0021:FR:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:205:0015:0021:ES:PDF or http://members.wto.org/crnattachments/2011/sps/EEC//11_2727_00_e.pdf http://members.wto.org/crnattachments/2011/sps/EEC//11_2727_00_f.pdf http://members.wto.org/crnattachments/2011/sps/EEC//11_2727_00_s.pdf
Products Covered:
Regulation Type: Addendum 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 2011-16089 appearing on page 37690 in the issue of Tuesday, 28 June 2011, make the following correction: ; ; On page 37690, in the first column, in the twelfth line from the bottom of the page, methacryloxyethyl)phenstyamino] should read methacryloxyethyl)phenlyamino]. ; ; Full Text URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-08-11/html/C1-2011-16089.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-08-11/pdf/C1-2011-16089.pdf ; ; ;
Distribution date: 22 August 2011 | Final date for Comment: 14 May 2025
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Corrigendum to Regular Notification
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