<pre><p>TITLE: Use of Materials Derived From Cattle in Human Food and Cosmetics</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule; adoption of interim final rule as final with amendments</p><p>SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. We have designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). We are taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. </p><p>DATES: This final rule is effective on 18 April 2016.</p></pre>
Distribution date: 23 March 2016
Products Covered: Human foods, cosmetics (HS 33-3, 2106) (ICS 71.100, 67.040, 07.100)
Regulation Type: Addendum to Regular Notification
<pre><p>TITLE: Use of Materials Derived From Cattle in Human Food and Cosmetics</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule; adoption of interim final rule as final with amendments</p><p>SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. We have designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). We are taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. </p><p>DATES: This final rule is effective on 18 April 2016.</p></pre>
Distribution date: 23 March 2016
Products Covered: Human foods, cosmetics (HS 33-3, 2106) (ICS 71.100, 67.040, 07.100)
Regulation Type: Addendum to Regular Notification
Use of Materials Derived From Cattle in Human Food and Cosmetics; Final rule; adoption of interim final rule as final with amendments
Distribution date: 21 March 2016
The US Food and Drug Administration (FDA) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. FDA has designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). It is taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. The text is available at Federal Register 81 FR 14718, 18 March 2016 and https://www.gpo.gov/fdsys/pkg/FR-2016-03-18/pdf/2016-06123.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Use of Materials Derived From Cattle in Human Food and Cosmetics; Final rule; adoption of interim final rule as final with amendments
Distribution date: 21 March 2016
The US Food and Drug Administration (FDA) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. FDA has designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). It is taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. The text is available at Federal Register 81 FR 14718, 18 March 2016 and https://www.gpo.gov/fdsys/pkg/FR-2016-03-18/pdf/2016-06123.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Partial amendment to the Minimum Requirements for Biological Products (1 page, in English)
Distribution date: 18 March 2016 | Final date for Comment: 21 March 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">The Minimum Requirements for Biological Products </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">is to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">be partially amended to add the standard for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">two </span><span style="font-size:x-small;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">vaccine product</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">s and a blood product to be newly approved.</span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 page, in English)
Distribution date: 18 March 2016 | Final date for Comment: 21 March 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">The Minimum Requirements for Biological Products </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">is to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">be partially amended to add the standard for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">two </span><span style="font-size:x-small;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">vaccine product</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">s and a blood product to be newly approved.</span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Radiopharmaceuticals
Distribution date: 18 March 2016 | Final date for Comment: 21 March 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The Minimum Requirements for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Radiopharmaceuticals </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">are to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">be partially amended to add the standard</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">s </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">a radiopharmaceutical </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">to be newly approved.</span></span></span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Radiopharmaceuticals
Distribution date: 18 March 2016 | Final date for Comment: 21 March 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The Minimum Requirements for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Radiopharmaceuticals </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">are to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">be partially amended to add the standard</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">s </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">a radiopharmaceutical </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">to be newly approved.</span></span></span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Draft Thai Industrial Standard for Hot Rolled Flat Steel for General Structure (TIS 1479-25xx) (16 pages, in Thai)
Distribution date: 15 March 2016 | Final date for Comment: 14 May 2016
<span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 1479-2541 (1998) Hot-rolled carbon steel coil, strip, plate and sheet for general structure, and replace it with </span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">TIS 1479-25xx Hot rolled flat steel for general structure </span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">as a mandatory standard.</span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;"><span> </span>This draft standard applies to hot rolled flat steel (unalloyed and alloy steel) for general structure i.e. bridge, ship, rolling stock.<span> </span>It specifies types and grades; chemical compositions; </span><span style="background:white;font-family:'Verdana', 'sans-serif';font-size:9pt;">mechanical properties</span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">; basis mass, sizes and tolerances; general requirements; marking and labeling; sampling and criteria for conformity.</span>
Products Covered: Hot-rolled flat steel (HS: 7208, ICS: 77.140.50)
Regulation Type: Revision to Regular Notification
Draft Thai Industrial Standard for Hot Rolled Flat Steel for General Structure (TIS 1479-25xx) (16 pages, in Thai)
Distribution date: 15 March 2016 | Final date for Comment: 14 May 2016
<span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 1479-2541 (1998) Hot-rolled carbon steel coil, strip, plate and sheet for general structure, and replace it with </span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">TIS 1479-25xx Hot rolled flat steel for general structure </span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">as a mandatory standard.</span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;"><span> </span>This draft standard applies to hot rolled flat steel (unalloyed and alloy steel) for general structure i.e. bridge, ship, rolling stock.<span> </span>It specifies types and grades; chemical compositions; </span><span style="background:white;font-family:'Verdana', 'sans-serif';font-size:9pt;">mechanical properties</span><span style="font-family:'Verdana', 'sans-serif';font-size:9pt;">; basis mass, sizes and tolerances; general requirements; marking and labeling; sampling and criteria for conformity.</span>
Products Covered: Hot-rolled flat steel (HS: 7208, ICS: 77.140.50)
Regulation Type: Revision to Regular Notification
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