March 12, 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

Filed on: 03/12/2019 at 8:45 am Scheduled Pub. Date: 03/13/2019

FR Document: 2019-04226 PDF 45 Pages (295 KB) Permalink

Withdrawal of Approval of New Animal Drug Application

Filed on: 03/12/2019 at 8:45 am Scheduled Pub. Date: 03/13/2019

FR Document: 2019-04222 PDF 2 Pages (83.6 KB) Permalink

Animal and Plant Health Inspection Service

Notices

Environmental Assessments; Availability, etc.:

Verdeca LLC; Nonregulated Status of Soybean Genetically Engineered for Yield Increase and Resistance to Glufosinate

Filed on: 03/12/2019 at 8:45 am Scheduled Pub. Date: 03/13/2019

FR Document: 2019-04537 PDF 7 Pages (185 KB) Permalink

International Trade Administration

Notices

Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Frozen Fish Fillets from the Socialist Republic of Vietnam; 2017-2018

Filed on: 03/12/2019 at 8:45 am Scheduled Pub. Date: 03/13/2019

FR Document: 2019-04623 PDF 10 Pages (113 KB) Permalink

USDA

Secretary Perdue Statement on President Trump’s Budget Proposal

FSIS

Recalls

Product Recalled	Date of Recall
026-2019 Choice Canning Company, Inc. Recalls Chicken Fried Rice Products Due to Misbranding and Undeclared Allergens	Mar 11, 2019

AMS

USDA Settles a Case with the Lynn R. Hottle, D.B.A. Hottle Livestock Resulting in a $1,250 Penalty

USDA Reaches a Consent Decision with Warren Hudspeth d/b/a 56 Cattle Co.

FTC

FTC Submits Annual Budget Request, Performance Plan and Performance Report to Congress

@SGottliebFDA

• · Today, #FDA requested new funding in the President’s FY2020 budget to continue to advance robust reg. framework for e-cigarettes oversight, prevent youth access/initiation & harness innovation to advance safety of food, compounded drugs, U.S. blood supply https://go.usa.gov/xEAYE

@USDAFoodSafety

• · #RecallAlert: Hometown Food Company announces voluntary recall on select Pillsbury Unbleached All Purpose Flour products because they may be contaminated with Salmonella. The flour products were sold through a limited number of retailers including Publix & Winn-Dixie. Do not eat.

@FDA_ORA

• · Routine #ProduceSafetyRule inspections by FDA and the states of large farms (sell an average of > $500K/year) other than sprout operations will begin this month! Check out FDA’s resources for states & farmers: https://go.usa.gov/xEfQK

@FTC

• · Q: Is it good enough if an endorser says “thank you” to the sponsoring company? (1/4) #InfluencerTips #Influencers101 #FTCTips
• · FTC Endorsement Guides: No. A “thank you” to a company or a brand doesn’t necessarily communicate that the endorser got something for free or that they were given something in exchange for an endorsement. (2/4)
• · A person posting on social media could just be thanking a co. or brand for providing a great product or service. “Thanks XYZ for the free product” or “Thanks XYZ for the gift of ABC product” would work – if that’s all you got from XYZ. Too long? There's “Sponsored” or “Ad.” (3/4)
• · Check out our handy Do's and Don'ts for Social Media Influencers infographic. Learn more on the FTC’s Endorsement Guides: What People Are Asking: https://www.ftc.gov/tips-advice/business-center/guidance/ftcs-endorsement-guides-what-people-are-asking … (4/4)

March 13, 2019

Federal Register

Food and Drug Administration

Notices

Food and Drug Administration Modernization Act of 1997:

Modifications to the List of Recognized Standards, Recognition List Number: 051

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04710 PDF 16 Pages (171 KB) Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04764 PDF 3 Pages (115 KB) Permalink

• Ø Survey of Customers of the Official Grain Inspection and Weighing System

Agricultural Marketing Service

Rules

Pears Grown in Oregon and Washington:

Change in Committee Structure for Processed Pears

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04782 PDF 12 Pages (256 KB) Permalink

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04775 PDF 5 Pages (111 KB) Permalink

• Ø Livestock, Poultry, and Grain Market News (LPGMN)

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04778 PDF 4 Pages (84.2 KB) Permalink

• Ø Federal Seed Act Program

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04780 PDF 4 Pages (82.7 KB) Permalink

• Ø Seed Service Testing Program

Environmental Protection Agency

Rules

Tolerances and Exemptions for Pesticide Chemical Residues in Food; CFR Correction

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04793 PDF 1 Page (97.4 KB) Permalink

Consumer Product Safety Commission

Notices

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

Flammability Standards for Children's Sleepwear

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04687 PDF 5 Pages (87.9 KB) Permalink

Safety Standard for Automatic Residential Garage Door Operators

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04706 PDF 4 Pages (83.9 KB) Permalink

Safety Standard for Omnidirectional Citizens Band Base Station Antennas

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04685 PDF 4 Pages (84 KB) Permalink

Safety Standard for Walk-Behind Power Lawn Mowers

Filed on: 03/13/2019 at 8:45 am Scheduled Pub. Date: 03/14/2019

FR Document: 2019-04686 PDF 4 Pages (85.3 KB) Permalink

FDA

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
11/06/2018	Ruben's Inc.	Denver District Office	CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated	Not Issued *

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
028-2019 North Country Smokehouse Recalls Pork Sausage Products Due to Misbranding	Mar 12, 2019	N/A (Class II Recall)
027-2019 Carnivore Meat Company, LLC Recalls Beef and Pork Sausage Products Due to Misbranding and Undeclared Allergens	Mar 12, 2019	N/A (Class II Recall)
024-2019 Washington Beef, LLC Recalls Ground Beef Products due to Possible Foreign Matter Contamination | En Español	Mar 02, 2019	Mar 11, 2019

AMS

USDA Announces American Egg Board Appointments

USDA Announces $4 Million in Grants Available to Support the Maple Syrup Industry

BRS

USDA APHIS Announces Availability of Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Petition to Deregulate GE Soybean for Increased Yield and Herbicide Resistance

OEHHA

Acceptance of a Request for a Safe Use Determination for Exposures to Bisphenol A in Certain Eyewear Products Manufactured, Distributed or Sold by the Vision Council Member Companies, and Opportunity for Public Comment

• Ø This request is limited to exposures to bisphenol A from the specified eyewear products (prescription glasses, OTC reading glasses, non-prescription sunglasses, and safety glasses).

Acceptance of a Request for a Safe Use Determination for Exposures to Crystalline Silica in WOODWISE® Products, and Opportunity for Public Comment

• Ø This request is limited to exposures to crystalline silica (airborne particles of respirable size) from the four specified WOODWISE® wood filler products.

Chemical Listed Effective March 8, 2019 as Known to the State of California to Cause Reproductive Toxicity: Bevacizumab

• Ø The listing of bevacizumab is based on a formal requirement by the US Food and Drug Administration that the chemical be identified or labeled as causing reproductive toxicity.

@SGottliebFDA

• · I’m delighted by the announcement from @SecAzar that @NCIDirector will serve as acting commissioner of #FDA. Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.
• · UPDATE: Claire’s is complying with the #FDA’s recall request and issuing a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. http://go.usa.gov/xEABt
• · Last week, #FDA requested that Claire’s issue a recall for three cosmetics products that were confirmed to be contaminated with asbestos. FDA issued a safety alert to warn consumers not to use these products. http://go.usa.gov/xEABt
• · FDA has limited tools and resources to ensure cosmetics safety, so I’d like to reinforce our ask to industry to take important new steps to ensure the safety of cosmetics products and protect consumers. We outlined those steps here: http://go.usa.gov/xEABS
• · We’ll soon be working with cosmetics manufacturers and requesting information about what procedures they use to ensure their cosmetics are safe and, in particular, about how they ensure that talc used in any cosmetic product is free from asbestos.

@NCIDirector

• · (1/3) Change is good, but bittersweet. It is difficult for me to say goodbye to @theNCI family as I head to @FDA to serve as acting commissioner. Rest assured that our shared goals for patients and the public’s health will translate into my new duties.
• · (2/3) I want to thank @POTUS, @SecAzar, & @SGottliebFDA for their support and encouragement.
• · (3/3) I also want to thank the amazing team at @theNCI for their professionalism and passion. Your dedication inspires me. I know you will be in great hands with @NCIDrDoug as the acting @NCIDirector.

@FrankYiannasFDA

• · THREAD: After #FDA issued a safety alert last week about three Claire’s cosmetic products containing asbestos, Claire’s is moving forward with FDA’s request to issue a voluntary recall of the contaminated products: http://go.usa.gov/xEABt
• · Due to limited tools, we are dependent on manufacturers to take steps to ensure the safety of their cosmetics products. We are calling on manufacturers to improve their oversight for risks such as those we identified with the Claire’s products. Learn more: http://go.usa.gov/xEABS

@USCPSC

• · #Recall: @HP batteries for notebook computers and mobile workstations can overheat, posing fire and burn hazards. Get free battery replacement. CONTACT: 866-671-7362 or check your battery at http://www.HP.com/go/batteryprogram2018 …. Full recall notice: http://bit.ly/2T0uZLV

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