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Laws and Regulations Committee Update 4/1 - 4/2, 2019

April 05, 2019 9:15 AM | Amy Bonsell (Administrator)

April 1, 2019

Federal Register

Food and Drug Administration

Rules

Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06141 PDF 5 Pages (86.1 KB) Permalink

  • Ø  Technical amendments to 21 CFR Parts 112, 117, and 507

New Animal Drugs:

Approval of New Animal Drug Applications; Changes of Sponsorship

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06136 PDF 36 Pages (285 KB) Permalink

  • Ø  Approval of nine animal drugs
  • Ø  Technical amendments to 21 CFR Parts 510, 520, 522, 524, 528, 556, and 558

 

Food Safety and Inspection Service

Notices

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

Import of Undenatured Inedible Product and Samples for Laboratory Examination, Research, Evaluative Testing, or Trade Show Exhibition

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06298 PDF 8 Pages (214 KB) Permalink

 

Registration Requirements

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06299 PDF 8 Pages (213 KB) Permalink

 

Agricultural Marketing Service

Rules

Federal Milk Marketing Orders:

Class I Skim Milk Price Formula; Correction

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date:04/02/2019

FR Document: 2019-06335 PDF 2 Pages (67.4 KB) Permalink

 

Food and Nutrition Service

Notices

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

Federal Claims Collection Methods for Supplemental Nutrition Assistance Program Recipient Claims

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06318 PDF 9 Pages (242 KB) Permalink

 

Environmental Protection Agency

Rules

Pesticide Tolerances:

Metrafenone

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06334 PDF 18 Pages (126 KB) Permalink

 

Zoxamide

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06333 PDF 16 Pages (122 KB) Permalink

 

Tolerance Exemption:

2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonic acid monosodium salt polymer with 2-propenoic acid, 2-methyl-, C12-16 alkyl esters

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06383 PDF 13 Pages (242 KB) Permalink

 

Health and Human Services Department

Notices

Meetings:

Biodefense Summit: Implementing the National Biodefense Strategy

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06330 PDF 4 Pages (162 KB) Permalink

 

International Trade Administration

Notices

Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Freshwater Crawfish Tail Meat from the People's Republic of China

Filed on: 04/01/2019 at 8:45 am Scheduled Pub. Date: 04/02/2019

FR Document: 2019-06314 PDF 8 Pages (157 KB) Permalink

 

FDA

Date

Brand

Product Description

Reason/Problem

Company

03/29/2019

Muse

Wet Cat Food

Product could contain rubber pieces

Nestle Purina PetCare Company

 

FSIS

Recalls

Product Recalled

Date of Recall

039-2019 Market of Choice, Inc. Recalls Pork and Poultry Products Due to Misbranding and Undeclared Allergens

Mar 30, 2019

 

AMS

USDA Chicken Fajita Purchase Program Announced March 29, 2019

USDA Section 32 Canned Pumpkin Purchase Program Announced

USDA Peanut Barter Announced

 

 

@SGottliebFDA

  • Ø  Today’s #FDA #SundayTweetorial is personal. I look back at what we've accomplished at FDA to advance innovations to benefit patients, promote policies to protect consumers, and address public health challenges during the two years I've shared these experiences with my colleagues.
  • Ø  FDA made great strides protecting and promoting public health the past two years, thanks to the dedication and scientific prowess of our talented workforce. While this is my last week at FDA, I’m confident in the future, and proud to have shared these and other efforts with them.
  • Ø  Over the past two years, we’ve also supported a number of major legislative efforts: To secure a more modern framework for the efficient regulation of diagnostic tests https://go.usa.gov/xEJ6B , to reform how over-the-counter drugs come to market…
  • Ø  ...and to reauthorize two animal drug user fee programs that enhance our ability to maintain a predictable, timely animal drug review process, foster innovation in drug development, expedite access to new therapies for food-producing and companion animals https://go.usa.gov/xEhXJ
  • Ø  The Food Safety and Modernization Act of 2011 (FSMA) greatly enhanced #FDA’s ability to fulfill its critical role of protecting the food supply through an emphasis on preventing risk. During my tenure we’ve worked hard to implement #FSMA https://go.usa.gov/xEhXH
  • Ø  One area where #FDA can have a profound, generational, and transformative impact on human health - outweighing any single medical innovation or intervention that we could discover - is through advances in nutrition and diet.
  • Ø  Our 2018 Nutrition Innovation Strategy https://go.usa.gov/xEJA5  seeks to reduce preventable death and disease caused by poor nutrition by ensuring that consumers have accurate useful info to make healthy food choices and also by fostering the development of healthier food options.
  • Ø  Poor nutrition plays a role in heart disease, cancer and obesity and yet about 75% of the population has a diet low in vegetables, fruits, dairy and healthier oils; and most Americans exceed the recommended intake of added sugars, saturated fat and sodium https://go.usa.gov/xEhba .
  • Ø  #FDA also has efforts underway to bring oversight of the exploding dietary supplements market into the 21st Century. Our current initiatives are aimed at protecting the public from bad actors without burdening responsible companies https://go.usa.gov/xEhjC .
  • Ø  Our Action Plan advances policy priorities we’ll pursue to clarify our science-and-risk-based approach for product developers; avoid unnecessary barriers to innovation in plant and animal biotechnology; and advance safety and our public health mission https://go.usa.gov/xEhDZ .
  • Ø  Other parts of #FDA are adapting to cutting-edge technology as well. Consider the promising new technologies that can edit animal and plant genomes with the potential to improve human/animal health, food productivity, animal well-being and food security https://go.usa.gov/xEJPG .
  • Ø  Honored to join Mark McClellan this morning at ⁦@pewtrusts⁩ to reflect on the strength of #FDA and the enduring nature of the policy work that underpins its mission. https://www.fiercebiotech.com/biotech/gottlieb-reflects-his-tenure-before-joining-club-ex-fda-chiefs

@FrankYiannasFDA

@FDAfood

 

April 2, 2019

Federal Register

Food and Drug Administration

Proposed Rules

Beverages:

Bottled Water

Filed on: 04/02/2019 at 8:45 am Scheduled Pub. Date: 04/03/2019

FR Document: 2019-06201 PDF 17 Pages (272 KB) Permalink

  • ·        FDA is proposing to revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L).

 

Public Hearing:

Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds

Filed on: 04/02/2019 at 8:45 am Scheduled Pub. Date: 04/03/2019

FR Document: 2019-06436  PDF 24 Pages (262 KB) Permalink

 

Animal and Plant Health Inspection Service

Proposed Rules

Evaluation and Recognition of the Animal Health Status of Compartments

Filed on: 04/02/2019 at 8:45 am Scheduled Pub. Date: 04/03/2019

FR Document: 2019-06473 PDF 17 Pages (210 KB) Permalink

 

FDA

FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards

Recalls

Date

Brand

Product Description

Reason/Problem

Company

04/01/2019

NadaMoo!

Strawberry Cheesecake Non-Dairy Frozen

Undeclared Almond

Little Red Rooster Ice Cream Company, d/b/a NadaMoo!

 

FSIS

Mar 29, 2019 | PDF

  • FSIS Retail Lm Pilot Project Update

 

AMS

USDA Clarifies Effective Date of Class I Skim Milk Price Formula

USDA Oven Roasted Chicken Purchase Program Announced

 

CVM

FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals

 

White House

Presidential Message for Winning on Reducing Food Waste Month

 

@SGottliebFDA

  • ·        The #FDA will be finalizing our homeopathy guidance soon, outlining our risk based approach to enforcement. We’re increasingly concerned by a proliferation of homeopathy products that don’t offer any demonstrated benefits and create risks to consumers. https://wholefoodsmagazine.com/suppliers/news-suppliers/fda-issues-warning-letters-for-cgmp-violations/
  • ·        THREAD: #FDA is announcing a funding opportunity that’ll help target and define durations of use for certain medically important antimicrobial drugs in the feed of food-producing animals. The grants may provide up to $1.5M
  • ·        The aim is to help generate publicly available data that sponsors of affected approved animal drug applications can use to update product dosage regimens to better target when and for how long their drugs may be used.
  • ·        Defining more targeted durations of use supports our ongoing efforts to slow the development of antimicrobial resistance and helps preserve the effectiveness of these antimicrobials in both veterinary and human medicine. Learn how to apply here: https://go.usa.gov/xmqVk

@FrankYiannasFDA

  • ·        The funds we’re requesting will help us leverage new and emerging technologies to create a more digital, traceable, diverse, and safer food system. #smarterfoodsafety https://t.co/Y93wwXdmvG

@FDASpox

  • ·        FDA posts warning letters to four companies who manufacture homeopathic drug products for significant violations and quality issues with their products. https://go.usa.gov/xmqdD

 


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