21 CFR Chapter I, Subchapter A - GENERAL

The Food and Drug Administration (FDA) is correcting a final order entitled “Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator” that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.

With the issuance of this final rule, the Drug Enforcement Administration removes the substance naldemedine (4 R,4a S,7a R,12b S )-3-(cyclopropylmethyl)-4a,7,9-trihydroxy- N -(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1 H -4,12-methanobenzofuro[3,2- e ]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, naldemedine was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine.

The Food and Drug Administration (FDA or we) is announcing that Idemitsu Kosan, Cp. Ltd. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as a carrier for flavors for use in animal feed.

The Food and Drug Administration (FDA) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of chromium DL-methionine as a nutritional source of chromium in cattle feed.

The Food and Drug Administration (FDA or we) is confirming the effective date of August 3, 2017, for the final rule that appeared in the Federal Register of July 3, 2017, and that amended the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.

The Food and Drug Administration (FDA or we) is announcing that Arcadia Biosciences, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of gamma-linolenic acid (GLA) safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. We are proposing to extend the compliance dates to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic opioids, N -(2-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)propionamide ( ortho -fluorofentanyl or 2-fluorofentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenyltetrahydrofuran-2-carboxamide (tetrahydrofuranyl fentanyl), and 2-methoxy- N -(1-phenethylpiperidin-4-yl)- N -phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids.

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule the synthetic cannabinoid, Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate [FUB-AMB, MMB-FUBINACA, AMB-FUBINACA], into Schedule I. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, importation, exportation of, and research and conduct with, instructional activities of this synthetic cannabinoid.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.” This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” The newly available draft chapter is entitled “Chapter Six—Use of Heat Treatments as a Process Control.”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need To Know About the FDA Regulation: Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration.”

The Food and Drug Administration (FDA or we) is correcting a notice that appeared in the Federal Register of Wednesday, July 26, 2017 (82 FR 34615). The document announced that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D 3 with absolute values and to update the specifications for vitamin D 3. The document was published with incorrect information on the absolute level of added calcium for fruit juice drinks that are fortified with calcium. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is amending the Medical Device Classification Procedures regulation to reflect a change in address for the Center for Devices and Radiological Health (CDRH). This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA or we or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of oil from a variety of bioengineered safflower as a source of omega-6 fatty acids in complete dry adult maintenance dog food. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled “Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry.” The guidance advises manufacturers who wish to use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF nonfat milk) in the production of standardized cheeses and related cheese products that, pending completion of a rulemaking regarding the use of UF milk in the production of these products, we intend to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products. We also intend to exercise enforcement discretion regarding the declaration of ingredients in the labeling of standardized cheeses and related cheese products when fluid UF milk and fluid UF nonfat milk are used as ingredients.

The Drug Enforcement Administration (DEA) proposes to remove naldemedine (4 R, 4a S, 7a R, 12b S )-3-(cyclopropylmethyl)-4a,7,9-trihydroxy- N -(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1 H -4,12-methanobenzofuro[3,2- e ]isoquinoline-6-carboxamide) including its salts from the schedules of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Naldemedine is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle naldemedine.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.” The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled “Part 11, Electronic Records; Electronic Signatures—Scope and Application” issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations.