Laws and Regulations Committee Update – November 23 – 24, 2020

November 23, 2020

Federal Register

Consumer Product Safety Commission

Notices

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

Safety Standard for Bicycle Helmets

Filed on: 11/23/2020 at 8:45 am Scheduled Pub. Date: 11/24/2020

FR Document: 2020-25949 PDF 3 Pages (76 KB) Permalink

Food and Nutrition Service

Rules

Child Nutrition Programs:

Rescission of Milk, Whole Grains, and Sodium Flexibilities: Notice of Vacatur

Filed on: 11/23/2020 at 8:45 am Scheduled Pub. Date: 11/24/2020

FR Document: 2020-25760 PDF 17 Pages (192 KB) Permalink

FDA

FDA COVID-19 Response – At-A-Glance Summary

Recalls

DateBrandProductProduct TypeRecall ReasonCompany
11/21/2020Dole and Wild HarvestOrganic Romaine HeartsFood & Beverages, Produce, Foodborne IllnessPotential for Pathogenic non-O157 E. coliDole Fresh Vegetables Inc.

Warning Letters

Posted DateIssue DateCompanyIssuing OfficeSubject
11/20/202011/18/2020Vibrant Health Care, Inc.Center for Biologics Evaluation and Research (CBER)Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

FSIS

FSIS Issues Public Health Alert for Chicken and Beef Samosa Products Containing Pastry Ingredients That Have Been Recalled Due to Misbranding

Constituent Updates

Nov 20, 2020 | PDF

  • FSIS, FDA, and CDC Post Outbreak Data
  • FSIS to Host Midwestern Laboratory Open House
  • Tips for Faster Label Approval Process
  • New Flexibilities for Establishments Working with New Antimicrobial Interventions
  • PHIS Export Module Billing Enhancement

GAO

CDC Could Further Strengthen Its Efforts to Identify and Respond to Foodborne Illnesses

November 24, 2020

Federal Register

Health and Human Services Department

Rules

–          Policy on Redundant, Overlapping, or Inconsistent Regulations

Filed on: 11/24/2020 at 8:45 am Scheduled Pub. Date: 11/27/2020

FR Document: 2020-26023 PDF 2 Pages (60.2 KB) Permalink

–          Statement of Policy:

Public Access to Materials Underlying Impact Analyses

Filed on: 11/24/2020 at 8:45 am Scheduled Pub. Date: 11/27/2020

FR Document: 2020-25957 PDF 2 Pages (69.5 KB) Permalink

Proposed Rules

–          Request for Information on Redundant, Overlapping, or Inconsistent Regulations

Filed on: 11/24/2020 at 8:45 am Scheduled Pub. Date: 11/27/2020

FR Document:2020-26022 PDF 2 Pages (60.3 KB) Permalink

Food and Nutrition Service

Proposed Rules

Restoration of Milk, Whole Grains, and Sodium Flexibilities

Filed on: 11/24/2020 at 8:45 am Scheduled Pub. Date: 11/25/2020

FR Document: 2020-25761 PDF 69 Pages (337 KB) Permalink

FDA

Why the United States-Mexico-Canada Agreement is Important to FDA

Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Guidance for Industry and FDA Staff

Recalls

DateBrandProductProduct TypeRecall ReasonCompany
11/23/2020CORE, Immune BoostCORE essential nutrients and Immune Boost Sublingual Vitamin D3Dietary Supplements, Drugs,Unapproved new drugFusion Health and Vitality LLC

USDA

USDA Shares Easy At-Home Advice for Handling Food Safely this Thanksgiving

USDA Launches AskUSDA, Improves and Streamlines Customer Experience

@FrankYiannasFDA

  • Today, we issued final FDA guidance on when & how the agency intends to make public retail consignee lists. Our goal is to help consumers identify recalled human/animal foods & determine if any is in their possession. #protect https://go.usa.gov/x7wJt

@SteveFDA

  • We have resumed prioritized domestic surveillance inspections and are using all available tools & sources of information to support regulatory decisions on applications that include sites impacted by FDA’s ability to inspect due to #COVID19.
  • The FDA is also expanding the use of other tools and approaches that have proven effective to help ensure the quality of drug products imported into the United States during this interim period, when possible.
  • This is just one of the many ways we are working to ensure that we continue to fulfill our critical public health responsibilities and maintain our high standards during the pandemic.