TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule; correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of 3 May 2012 (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error. ; ; DATES: Effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/html/2012-12594.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-24/pdf/2012-12594.pdf ;
Distribution date: 08 June 2012 | Final date for Comment: 14 May 2025
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Corrigendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products. ; ; DATES: This rule is effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/html/2012-10649.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/pdf/2012-10649.pdf ; ;
Distribution date: 08 June 2012 | Final date for Comment: 14 May 2025
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Addendum to Regular Notification
TITLE: Amendments to Sterility Test Requirements for Biological Products ; ; AGENCY: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) ; ; ACTION: Final rule ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products. ; ; DATES: This rule is effective 4 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/html/2012-10649.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-03/pdf/2012-10649.pdf ; ;
Distribution date: 08 June 2012 | Final date for Comment: 14 May 2025
Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)
Regulation Type: Addendum to Regular Notification
TITLE: Elemental Mercury Used in Barometers, Manometers, Hygrometers, and Psychrometers; Significant New Use Rule ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final Rule ; ; SUMMARY: EPA is promulgating a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for elemental mercury use in barometers, manometers, hygrometers, and psychrometers. This action will require persons who intend to manufacture (including import) or process elemental mercury for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. ; ; DATES: This final rule is effective 29 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/html/2012-13071.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/pdf/2012-13071.pdf ;
Distribution date: 12 June 2012 | Final date for Comment: 14 May 2025
Products Covered: Elemental mercury (HS 2805.40, ICS 13.020, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Elemental Mercury Used in Barometers, Manometers, Hygrometers, and Psychrometers; Significant New Use Rule ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final Rule ; ; SUMMARY: EPA is promulgating a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for elemental mercury use in barometers, manometers, hygrometers, and psychrometers. This action will require persons who intend to manufacture (including import) or process elemental mercury for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. ; ; DATES: This final rule is effective 29 June 2012. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/html/2012-13071.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/pdf/2012-13071.pdf ;
Distribution date: 12 June 2012 | Final date for Comment: 14 May 2025
Products Covered: Elemental mercury (HS 2805.40, ICS 13.020, 71.100)
Regulation Type: Addendum to Regular Notification
Amendments of the Enforcement Ordinance of the Standards of Feed and Feed Additives (amendment of agricultural chemical residue standard)
Distribution date: 13 June 2012 | Final date for Comment: 12 August 2012
Japan proposes maximum residue limits (MRLs) for imidacloprid as follows. Commodity Proposed MRL (ppm(wt)) Current MRL (ppm(wt)) Corn grain , including field corn 0.05 0.1 Hay, including fodder, straw and silage 0.5 6
Products Covered: Corn (HS Code: 10.05) for feed Cereal straw, hay, lucerne (alfalfa), clover and other forage products (HS Codes: 12.13, 12.14) for feed
Regulation Type: Regular notification
Amendments of the Enforcement Ordinance of the Standards of Feed and Feed Additives (amendment of agricultural chemical residue standard)
Distribution date: 13 June 2012 | Final date for Comment: 12 August 2012
Japan proposes maximum residue limits (MRLs) for imidacloprid as follows. Commodity Proposed MRL (ppm(wt)) Current MRL (ppm(wt)) Corn grain , including field corn 0.05 0.1 Hay, including fodder, straw and silage 0.5 6
Products Covered: Corn (HS Code: 10.05) for feed Cereal straw, hay, lucerne (alfalfa), clover and other forage products (HS Codes: 12.13, 12.14) for feed
Regulation Type: Regular notification
KS 1529: 2012 Pomades and solid brilliantine Specification
Distribution date: 22 June 2012 | Final date for Comment: 21 August 2012
Prescribes requirements and methods of test for pomades and solid brilliantines. The standard applies to the following: ; i) pomades and solid brilliantines based on vegetable oils, mineral oils, animal fats, waxes, or fatty acids but excludes oil emulsions. ; i) pomades and solid brilliantine to which sulphur has been added as an intrinsic part of the formulation. ; i) iii) insect repellents manufactured in the form of pomades or solid brilliantines ;
Products Covered: Pomades and solid brilliantine (HS: 330590; ICS: 71.100.70)
Regulation Type: Regular notification
KS 1529: 2012 Pomades and solid brilliantine Specification
Distribution date: 22 June 2012 | Final date for Comment: 21 August 2012
Prescribes requirements and methods of test for pomades and solid brilliantines. The standard applies to the following: ; i) pomades and solid brilliantines based on vegetable oils, mineral oils, animal fats, waxes, or fatty acids but excludes oil emulsions. ; i) pomades and solid brilliantine to which sulphur has been added as an intrinsic part of the formulation. ; i) iii) insect repellents manufactured in the form of pomades or solid brilliantines ;
Products Covered: Pomades and solid brilliantine (HS: 330590; ICS: 71.100.70)
Regulation Type: Regular notification
National Standard of the P.R.C., Fire Extinguishing Agent Heptafluoropropane (HFC227ea) ( 13 pages, in Chinese)
Distribution date: 26 June 2012 | Final date for Comment: 25 August 2012
Chapters 4 and 6 of this standard are mandatory, the rest ones are recommended. The mandatory contents are the requirements and inspection rules for fire extinguishing agent heptafluoropropane.
Products Covered: Fire extinguishing agent heptafluoropropane ; ICSF13.220.10 HS: 3813 ;
Regulation Type: Regular notification
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