Laws and Regulations Committee Update – August 7-9, 2019

August 9, 2019 in Federal Register Updates

Federal Register

Food and Drug Administration

Notices

Advisory Committees; Filing of Closed Meeting Reports

Filed on: 08/07/2019 at 8:45 am Scheduled Pub. Date: 08/08/2019

FR Document: 2019-16992 PDF 3 Pages (79.3 KB) Permalink

Annual reports of FDA advisory committees that held closed meetings during FY 2018 have been filed with the Library of Congress

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Manufactured Food Regulatory Program Standards

Filed on: 08/07/2019 at 8:45 am Scheduled Pub. Date: 08/08/2019

FR Document: 2019-16937 PDF 3 Pages (11.9 KB) Permalink

Food and Nutrition Service

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Reasons for Underredemption of the WIC Cash-Value Benefit

Filed on: 08/07/2019 at 8:45 am Scheduled Pub. Date: 08/08/2019

FR Document: 2019-17016 PDF 8 Pages (528 KB) Permalink

Foreign Agricultural Service

Notices

Adjustment of Appendices under the Dairy Tariff-Rate Quota Import Licensing Regulation for the 2019 Tariff-Rate Quota Year

Filed on: 08/07/2019 at 8:45 am Scheduled Pub. Date: 08/08/2019

FR Document: 2019-16933 PDF 7 Pages (404 KB) Permalink

Assessment of Fees for Dairy Import Licenses for the 2020 Tariff-Rate Import Quota Year

Filed on: 08/07/2019 at 8:45 am Scheduled Pub. Date: 08/08/2019

FR Document: 2019-16932 PDF 3 Pages (102 KB) Permalink

FDA

GRAS Notices

GRN No.	Substance	Date of Closure	FDA’s Letter
816	Xylooligosaccharides from sugarcane	Apr 29, 2019	FDA has no questions (in PDF)⁸ (160 kB)
793	Cultured corn starch fermented by Corynebacterium stationis	Apr 26, 2019	FDA has no questions (in PDF)⁹ (171 kB)
792	Cultured corn starch fermented by Corynebacterium glutamicum	Apr 26, 2019	FDA has no questions (in PDF)¹⁰ (160 kB)
810	Lactobacillus paracasei subsp. paracasei strain F-19e	Apr 5, 2019	FDA has no questions (in PDF)¹¹ (178 kB)
820	Lactobacillus fermentum CECT5716	Apr 3, 2019	At the notifier’s request, FDA ceased to evaluate this notice (in PDF)¹² (35.2 kB)

Warning Letters

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject
08/06/2019	07/12/2019	Atlantic Bakery Ltd. d.b.a. Old School Bakery	Division of Human and Animal Food Operations East IV	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
08/06/2019	07/24/2019	Sinu Co., Ltd	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
08/06/2019	07/29/2019	Premium Production LLC	Division of Human and Animal Food Operations West IV	CGMP/Dietary Supplement/Adulterated
08/06/2019	07/30/2019	U.F.S. Industries, Inc. d.b.a. Sally Sherman Foods	Division of Human and Animal Food Operations East I	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
08/06/2019	07/30/2019	Med Shop Total Care Inc.	Office of Pharmaceutical Quality Operations, Division II	Animal Drugs/Adulterated

FSIS

Aug 06, 2019 | PDF

FSIS Request Comments of Revised Performance Standards for Campylobacter

Recalls

Product Recalled	Date of Recall
082-2019 Top Taste Food Warehouse Recalls Meat and Poultry Products Produced Without Benefit of Inspection	Aug 06, 2019

@FrankYiannasFDA

Here’s my latest interview with @afdonews on FSMA & Smarter Food Safety. You can listen or watch at this link. https://afdo.podbean.com/e/smarter-food-safety-with-fdas-frank-yiannas/ … Better yet, join us. We can’t do this alone. #smarterfoodsafety

August 8, 2019

Federal Register

Food and Drug Administration

Rules

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors’ Names and Addresses

Filed on: 08/08/2019 at 8:45 am Scheduled Pub. Date: 08/09/2019

FR Document: 2019-16884 PDF 24 Pages (232 KB) Permalink

New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

Filed on: 08/08/2019 at 8:45 am Scheduled Pub. Date: 08/09/2019

FR Document: 2019-16885 PDF 2 Pages (84.3 KB) Permalink

Notices

Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs

Filed on: 08/08/2019 at 8:45 am Scheduled Pub. Date: 08/09/2019

FR Document: 2019-17053 PDF 7 Pages (186 KB) Permalink

Agriculture Department

Notices

Sugar Charged Against the FY 2019 Raw Sugar Tariff-Rate Quota May be Entered Until October 15, 2019

Filed on: 08/08/2019 at 8:45 am Scheduled Pub. Date: 08/09/2019

FR Document: 2019-17130 PDF 2 Pages (77.8 KB) Permalink

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
064-2019 Perdue Foods LLC Recalls Perdue Simply Smart Organics Poultry Products Due to Possible Foreign Matter Contamination \| En Español	May 31, 2019	Aug 07, 2019

@FrankYiannasFDA

Modern times require modern approaches. Here’s a link to the ‘FSMA & Smarter Food Safety’ update I was honored to provide on behalf of @US_FDA at @IAFPFood 2019 https://vimeo.com/351630044?ref=tw-share …

August 9, 2019

Federal Register

Food and Drug Administration

Proposed Rules

Kellogg Company; Filing of Food Additive Petition