21 CFR Chapter I, Subchapter L - REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
- PART 1210 - REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT (§§ 1210.1 - 1210.31)
- PART 1230 - REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT (§§ 1230.2 - 1230.49)
- PART 1240 - CONTROL OF COMMUNICABLE DISEASES (§§ 1240.3 - 1240.95)
- PART 1250 - INTERSTATE CONVEYANCE SANITATION (§§ 1250.3 - 1250.96)
- PARTS 1251-1269 [RESERVED]
- PART 1270 - HUMAN TISSUE INTENDED FOR TRANSPLANTATION (§§ 1270.1 - 1270.43)
- PART 1271 - HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (§§ 1271.1 - 1271.440)
- PARTS 1272-1299 [RESERVED]
Title 21 published on 06-Mar-2018 03:28
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to Title 21 after this date.
* Only displaying the most recent 50 entries for Title 21. Please, view a Part for the full list of changes within that Part.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-04775 RIN Docket No. FDA-2014-F-0469 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; withdrawal of petition for rulemaking. The food additive petition was withdrawn on November 10, 2017. 21 CFR Part 573 The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (animal use) proposing that the food additive regulations be amended to provide for the safe use of L-selenomethionine as a dietary source of selenium in feed for poultry, swine, and ruminants.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-04765 RIN Docket No. DEA-475 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Temporary amendment; temporary scheduling order; correcting amendment. Effective March 9, 2018 until February 1, 2020. 21 CFR Part 1308 On February 1, 2018, the Drug Enforcement Administration placed seven fentanyl-related substances temporarily in schedule I of the Controlled Substances Act. Incorrect drug codes were assigned to valeryl fentanyl and ocfentanil. This document corrects the drug codes for those two substances.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-04616 RIN Docket No. FDA-2018-N-0387 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective March 7, 2018. The classification was applicable on December 28, 2017. 21 CFR Part 878 The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal shock wave device for treatment of chronic wounds' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-04619 RIN Docket No. FDA-2018-C-0617 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of petition. Submit either electronic or written comments on the petitioner's environmental assessment by April 6, 2018. 21 CFR Part 73 The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by GW Cosmetics GmbH, proposing that the color additive regulations be amended to provide for the safe use of silver nitrate in professional-use only cosmetics to color eyebrows and eyelashes.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-04275 RIN Docket No. FDA-2017-F-5528 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 2, 2018. See section V of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by April 2, 2018. 21 CFR Part 573 The Food and Drug Administration (FDA, 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 silicon dioxide as a carrier for flavors for use in animal feed. This action is in response to a food additive petition filed by Idemitsu Kosan, Cp. Ltd.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-04281 RIN Docket No. FDA-2018-D-0075 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Submit either electronic or written comments by May 1, 2018 to ensure that we consider your comment before we take further action. 21 CFR Part 101 The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Guidance for Industry.” The draft guidance, when finalized, will advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol “†” immediately after the added sugars percent Daily Value information on certain foods. The symbol would lead the reader to truthful and non-misleading statements outside the Nutrition Facts label to provide additional information regarding the added sugars present in particular foods.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-03924 RIN Docket No. FDA 2018-N-0339 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective February 27, 2018. The classification was applicable on October 27, 2017. 21 CFR Part 864 The Food and Drug Administration (FDA or we) is classifying Lynch syndrome test systems into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Lynch syndrome test systems' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-03244 RIN 0910-AG48 Docket No. FDA-2013-N-0080 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective February 21, 2019. See section III of this document for additional explanation of the effective date of this final rule. 21 CFR Parts 807, 812, and 814 The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-03135 RIN Docket No. FDA-2018-N-0370 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective February 15, 2018. The classification was applicable on June 30, 2017. 21 CFR Part 878 The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-02757 RIN 0910-AH51 Docket No. FDA-2017-N-6381 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by April 30, 2018. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 16, 2018. 21 CFR Part 514 The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted to FDA in an electronic format that we can process, review, and archive. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-02319 RIN Docket No. DEA-476 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Temporary amendment; temporary scheduling order. This temporary scheduling order is effective February 6, 2018, until February 6, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register . 21 CFR Part 1308 The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle fentanyl-related substances.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-02202 RIN Docket No. FDA-2018-N-0371 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective February 5, 2018. The classification was applicable on November 15, 2017. 21 CFR Part 882 The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the percutaneous nerve stimulator for substance use disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-02008 RIN Docket No. DEA-475 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Temporary amendment; temporary scheduling order. This temporary scheduling order is effective February 1, 2018, until February 1, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register . 21 CFR Part 1308 The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule seven fentanyl-related substances in schedule I. These seven substances are: N -(1-phenethylpiperidin-4-yl)- N -phenylpentanamide (valeryl fentanyl), N -(4-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)butyramide ( para -fluorobutyryl fentanyl), N -(4-methoxyphenyl)- N -(1-phenethylpiperidin-4-yl)butyramide ( para -methoxybutyryl fentanyl), N -(4-chlorophenyl)- N -(1-phenethylpiperidin-4-yl)isobutyramide ( para -chloroisobutyryl fentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenylisobutyramide (isobutyryl fentanyl), N -(1-phenethylpiperidin-4-yl)- N -phenylcyclopentanecarboxamide (cyclopentyl fentanyl), and N -(2-fluorophenyl)-2-methoxy- N -(1-phenethylpiperidin-4-yl)acetamide (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, valeryl fentanyl, para -fluorobutyryl fentanyl, para -methoxybutyryl fentanyl, para -chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01912 RIN Docket No. FDA-2016-C-2767 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; confirmation of effective date. Effective date of final rule published in the Federal Register of November 7, 2017 (82 FR 51554) confirmed: December 8, 2017. 21 CFR Part 73 The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01638 RIN Docket No. FDA-2017-N-6285 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective January 30, 2018. The classification was applicable on June 1, 2017. 21 CFR Part 870 The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01639 RIN Docket No. FDA-2017-N-6598 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective January 30, 2018. The classification was applicable on December 20, 2016. 21 CFR Part 878 The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the surgical smoke precipitator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01747 RIN Docket No. DEA-421 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Notice of proposed rulemaking. Comments must be submitted electronically or postmarked on or before March 1, 2018. Interested persons may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before March 1, 2018. 21 CFR Part 1308 The Drug Enforcement Administration proposes placing N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle MAB-CHMINACA.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01746 RIN Docket No. DEA-421 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Temporary rule; temporary scheduling order; extension. This temporary scheduling order, which extends the final order (81 FR 6171, February 5, 2016), is effective February 5, 2018 and expires on February 5, 2019. If DEA publishes a final rule making this scheduling action permanent, this order will expire on the effective date of that rule, if the effective date is earlier than February 5, 2019. 21 CFR Part 1308 The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of MAB-CHMINACA currently is in effect through February 4, 2018. This temporary order will extend the temporary scheduling of MAB-CHMINACA for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01468 RIN 0910-AH49 Docket No. FDA-2017-N-7007 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Direct final rule. This rule is effective June 11, 2018. Submit either electronic or written comments on the direct final rule or its companion proposed rule by April 11, 2018. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends. 21 CFR Part 600 The Food and Drug Administration (FDA, Agency, or we) is amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01467 RIN 0910-AH49 Docket No. FDA-2017-N-7007 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule or its companion direct final rule by April 11, 2018. If FDA receives any timely significant adverse comments on the direct final rule with which this proposed rule is associated, the Agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. FDA will apply any significant adverse comments received on the direct final rule to the proposed rule in developing the final rule. FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures. 21 CFR Part 600 The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is proposing this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01300 RIN Docket No. FDA-2011-N-0143 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. The announcement of the guidance is published in the Federal Register on January 25, 2018. 21 CFR Part 1 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: 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 “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01298 RIN Docket No. FDA-2017-D-6592 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. The announcement of the guidance is published in the Federal Register on January 25, 2018. 21 CFR Part 1 The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a guidance for industry entitled “Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry.” This guidance is intended to explain our intent to exercise enforcement discretion for importers of grain raw agricultural commodities (RACs) that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import, but instead arrange for the delivery of the grain to others for storage, packing, or manufacturing/processing.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01297 RIN Docket No. FDA-2017-D-5225 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comments on this draft guidance before it completes a final version of the guidance, 21 CFR Part 1 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.” The draft guidance, once finalized, will provide our thinking on how importers of human or animal food can comply with the regulation on foreign supplier verification programs (FSVPs) issued on November 27, 2015.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01296 RIN Docket No. FDA-2017-D-0397 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. 21 CFR Parts 1, 112, 117, and 507 The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in Part 117 or 507.” The draft guidance describes FDA's current thinking on the concept of “same level of public health protection” (SLPHP), and FDA's expectations for how an SLPHP evaluation should be conducted and an SLPHP determination should be reached. The draft guidance identifies certain points to consider that a competent authority, a farm, a facility, an importer, or other relevant entity should take into consideration when evaluating whether a measure that is different from that required under (part 112) 21 CFR part 112 or the preventive controls requirements in (part 117 or part 507) 21 CFR part 117 or 507 meets the SLPHP threshold under the foreign supplier verification program (FSVP) regulation (21 CFR part 1, subpart L) or under part 112.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01299 RIN Docket No. FDA-2016-D-2343 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Submit either electronic or written comments by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. 21 CFR Part 117 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: Draft 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 15—Supply-Chain Program for Human Food Products.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-01173 RIN 1117-AB42 Docket No. DEA-450 DEPARTMENT OF JUSTICE, Drug Enforcement Administration Final rule. Effective: January 22, 2018. 21 CFR Part 1301 The Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services, by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The Drug Enforcement Administration (DEA) is hereby amending its regulations to incorporate these statutory and regulatory changes.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-00991 RIN Docket No. FDA-2017-N-5319 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public hearing; reopening of the comment period. FDA is reopening the comment period on the document published on September 26, 2017 (82 FR 44803). Submit either electronic or written comments by February 21, 2018. 21 CFR Part 15 The Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the sponsor for the approved, marketed drug does not wish to pursue or collaborate on the new use. In the document, in addition to seeking comments on the potential approach, FDA also welcomed comments on public health, scientific, regulatory, or legal considerations relating to other medical products intended for new uses with approved, marketed medical products of a different type where the sponsor for the approved, marketed product does not wish to pursue or collaborate on the new use. We are reopening the comment period in response to a request for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-00918 RIN Docket No. FDA-2016-D-3548 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. 21 CFR Part 7 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.” The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-00646 RIN 0910-AH37 Docket No. FDA-2016-N-2378 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments by April 17, 2018. See section V of this document for the proposed effective date of a final rule that may issue based on this proposal. 21 CFR Parts 10 and 800 The Food and Drug Administration (FDA) is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also proposing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-00683 RIN 0910-AH43 Docket No. FDA-2017-N-0763 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; extension of comment period. FDA is extending the comment period on the proposed rule published on October 31, 2017 (82 FR 50324). Submit either electronic or written comments by March 19, 2018. 21 CFR Part 101 The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule that appeared in the Federal Register of October 31, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-00550 RIN Docket No. FDA-2017-D-6841 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. The announcement of the guidance is published in the Federal Register on January 16, 2018. 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance for industry and FDA Staff entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.” This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for certain class I and unclassified devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Agency regulations for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under an Agency regulation for these devices before September 24, 2022. The policy described in this guidance does not apply to implantable, life-supporting, or life-sustaining devices. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-00555 RIN 0910-AH94 Docket No. FDA-2015-N-2002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; partial delay of effective date. Submit either electronic or written comments on this proposed rule by February 5, 2018. 21 CFR Parts 201, 801, and 1100 The Food and Drug Administration (FDA, the Agency, or we) is proposing to delay the effective date of certain portions of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. In the Federal Register of March 20, 2017, we further delayed the effective date of the final rule until March 19, 2018, and invited public comment on the rule. This action, if finalized, will delay until further notice the effective date of the portions of the final rule amending FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses. FDA received a number of comments on the final rule that raise questions about the amendments to the existing medical product “intended use” regulations. FDA is proposing to delay the effective date of the amendments to the existing medical product “intended use” regulations to allow further consideration of the substantive issues raised in the comments received. This action, if finalized, will not further delay the effective date of the new regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act).