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Issued by Food and Drug Administration

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Petition for rulemaking. SUMMARY: 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) … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; petition for rulemaking; correction. SUMMARY: 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 … [read more]

Start Preamble Start Printed Page 34615 AGENCY: Food and Drug Administration, HHS. ACTION: Notification; petition for rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; petition for rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of zinc-L-selenomethionine as a … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; notification of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.” … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Glo Eyes, LLC, proposing that the color additive regulations be amended to provide for the safe use of … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of formic acid as a feed acidifying … [read more]

Start Preamble Start Printed Page 20847 AGENCY: Food and Drug Administration, HHS. ACTION: Notification; denial of petition. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is denying a petition, submitted by the Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Children's Environmental Health … [read more]

Start Preamble Start Printed Page 18268 AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that the Canadian Oilseed Processors Association has filed a petition proposing that the food additive regulations be amended to provide for the … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of January 23, 2017. In the proposed rule, FDA … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of high … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled “Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry” that appeared in … [read more]

Start Preamble Start Printed Page 10868 AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled “Use of the Term `Healthy' in the Labeling of Human Food Products.” The … [read more]

Start Preamble Start Printed Page 8004 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing a tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products. FDA is taking this action because NNN is … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Reopening of comment period related to public hearing; availability of memorandum. SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the notification of public hearing, published in the Federal Register of September 1, 2016 (81 FR … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a revised draft guidance for industry entitled “Control of Listeria monocytogenes in Ready-To-Eat Foods.” The revised draft guidance is intended for any … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability of a draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; extension of comment period. SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of the term “healthy” in the labeling of human food … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition; reopening of the comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the notice of petition, published in the Federal Register of November 8, 2016 (81 FR 78528), proposing that the … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a revised draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” The revised draft guidance … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing a regulation to identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Fruit Juice and Vegetable Juice as Color Additives in Food.” The draft guidance, when finalized, will help … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of two proposed rules that published in the Federal Register more than 5 years ago. These proposed rules are no longer considered viable candidates for final … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that Novus International, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (2-vinylpyridine-co-styrene) as a nutrient … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” This draft guidance contains 15 … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of request for comments. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive comments, particularly data and other information, on the appropriate reference amount customarily consumed (RACC) and product category … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of August 24, 2016. In the proposed rule, FDA requested comments on … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; supplemental notice of proposed rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled “New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.” The document proposed … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. Start Printed Page 74369 SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as “essential uses” under the … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices … [read more]

Start Preamble Start Printed Page 69740 AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to provide … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that BASF Corp., as a part of their petition (FAP 2286) proposing that the food additive regulations be amended to provide for the safe use of feed grade … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notification; establishment of docket; request for comments. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the use of the term “healthy” in the labeling of human … [read more]

Start Preamble AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by McCormick & Company, Inc., proposing that the color additive regulations be amended to provide for the safe use … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Scope of the Public Hearing III. Attendance and Registration IV. Notice of Public Hearing Under 21 CFR Part 15 V. Transcripts Footnotes DATES: Back to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Introduction II. Background III. Description of the Proposed Rule A. Disqualification Proceedings (§ 511.1(c)(1)) B. Ineligibility To Receive Any Test Article (§ 511.1(c)(2)) C. Reinstatement (§ 511.1(c)(6)) IV. Regulatory Hearing before the … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is reopening the comment period on the notice of filing of a food additive petition published on May 20, 2016 (81 FR 31877). Submit either … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Regulatory Action II. Direct Final Rulemaking III. Purpose and Legal Authority A. Purpose … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Regulatory Action B. Summary of the Major Provisions of the Regulatory Action in Question C. Effectiveness D. Safety E. Active … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Abandonment DATES: Back to Top The food additive petition was filed on May 11, 2016. Submit either electronic or written comments by August 29, 2016. ADDRESSES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Abandonment DATES: Back to Top The food additive petition was filed on May 16, 2016. Submit either electronic or written comments by August 15, 2016. ADDRESSES: Back … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1188. SUPPLEMENTARY INFORMATION: Back to Top In … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is extending the comment period on the proposed rule published April 25, 2016 (81 FR 24386). Submit either electronic or written comments by July 25, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of 21 CFR Parts 175, 176, 177, and 178 § 175.105 Adhesives § 175.300 Resinous and Polymeric Coatings § 175.320 Resinous and Polymeric Coatings for Polyolefin Films § 176.170 Components of Paper and Paperboard … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Paperwork Reduction Act of 1995 IV. Electronic Access Tables Back to Top Table 1—Estimated Annual Reporting Burden 1 DATES: Back to Top Although you … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Back to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Electronic Access DATES: Back to Top Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Draft Guidance III. Paperwork Reduction Act of 1995 IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Electronic Access DATES: Back to Top Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Format of the Regional Outreach Meetings III. How To Participate in the Public Meeting Tables Back to Top Table 1—Information on Participation in the Meeting DATES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Enforcement III. Paperwork Reduction Act of 1995 IV. Electronic Access DATES: Back to Top Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Companion Document to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Abandonment DATES: Back to Top Submit either electronic or written comments by June 28, 2016. ADDRESSES: Back to Top You may submit comments as follows: Electronic Submissions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background DATES: Back to Top FDA is extending the comment period on the document published March 4, 2016 (81 FR 11477). Submit either electronic or written comments by June … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Proposed Rule Legal Authority Summary of the Major Provisions of the Proposed Rule Costs and Benefits of the Proposed Rule Table of Contents I. Background … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Draft Guidances III. Purpose and Scope of the Public Hearing IV. Attendance and Registration V. Notice of Hearing Under 21 CFR Part 15 VI. Transcripts Footnotes DATES: … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is extending the comment period on the four draft guidances announced in the Federal Register (see SUPPLEMENTARY INFORMATION). Submit either electronic or written comments by … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments by May 18, 2016. ADDRESSES: Back to Top You may submit comments as follows: Electronic Submissions Back to Top Submit … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Why is FDA publishing this proposed rule? III. Legal Authority IV. Analysis of Environmental Impact V. Economic Analysis of Impacts VI. Paperwork Reduction Act of 1995 VII. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose and Scope of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on February 19, 2016. FOR FURTHER INFORMATION CONTACT: Back to Top Laura Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. History of Powdered Gloves and Their Regulation B. Citizen Petitions C. Scope of the Ban D. Legal Standard II. Evaluation of Data and Information … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition was filed on February 12, 2016. FOR FURTHER INFORMATION CONTACT: Back to Top Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Statutory and Regulatory Authorities B. Regulatory History of the Device II. Recommendation of the Panel A. Identification B. Recommended Classification of the Panel C. Summary of Reasons … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Scope of the Public Hearing III. Notice of Hearing Under 21 CFR Part 15 DATES: Back to Top The public hearing will be held on … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Issues for Consideration A. Proposed Definitions of Third-Party and OEM Activities B. Evaluation of Risk Associated With These Third-Party and OEM Activities III. Paperwork Reduction Act of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification A. Single Patient Use Only Blood Lancets B. Multiple Patient Use Blood Lancets V. Public Health … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device III. Dates New Requirements Apply IV. Device Subject to This Proposal Multiple Use Blood Lancet for Multiple Patient Use (21 CFR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Statutory and Regulatory Authorities B. Regulatory History of the Devices II. Panel Recommendation A. Identification B. Recommended Classification of the Panel C. Risks to Health and Special … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top We are extending the comment period on the notice of filing of a food additive petition published on January 4, 2016 (81 FR 42). Submit either … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is reopening the comment period on the proposed rule published November 18, 2015 (80 FR 71990). Submit either electronic or written comments by April 25, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on information collection issues under the PRA by February 22, 2016. ADDRESSES: Back to Top Submit comments on information collection issues to the Office … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities A. Reclassification B. Requirement for Premarket Approval Application II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of § 172.515 III. Establish a Zero Tolerance DATES: Back to Top The food additive petition was filed on August 17, 2015. Submit either electronic or written … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities A. Reclassification B. Requirement for Premarket Approval Application II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of Reasons for Reclassification VII. … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top FDA is extending the comment period for a docket to receive information and comments on the use of the term “natural” in the labeling of human … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits II. Background A. Regulatory History 1. Fixed-Combination … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background and Legal Authority II. Risks Posed by the Device A. Increased Skin Cancer Risk From Cumulative, Repeated UV Radiation Exposure B. Ocular Injury C. Discomfort, Pain, and Tenderness … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action in Question Costs and Benefits Table of Contents I. Background II. Contents of the Proposed Regulation A. Overview … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The comment period for the proposed rule published on September 25, 2015 (80 FR 57756) is extended. Submit either electronic or written comments by December 30, … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition was filed on October 15, 2015. FOR FURTHER INFORMATION CONTACT: Back to Top Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Rule Table of Contents I. Background A. Why do we need this proposed rule? B. What are fermented or hydrolyzed foods? C. Why are there … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Regulatory Authorities B. Regulatory History—Background of the Device II. Panel Recommendation A. Classification Recommendation B. Summary of Reasons and Data To Support the Recommendations III. Proposed Classification … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. What has been FDA's position regarding the use of the term “natural?” B. What recent events prompted FDA to request comment? II. Request for Comments and Information … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Reopening of Comment Period DATES: Back to Top Submit either electronic or written comments on the draft guidance by April 29, 2016. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Draft Guidances III. Purpose and Scope of the Public Hearing IV. Attendance and Registration V. Notice of Hearing Under 21 CFR Part 15 VI. Transcripts DATES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Reopening of Comment Period DATES: Back to Top Submit either electronic or written comments on the draft guidance by April 29, 2016. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Reopening of Comment Period DATES: Back to Top Submit either electronic or written comments on the draft guidance by April 29, 2016. ADDRESSES: Back to Top You … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top This food additive petition was filed on October 1, 2015. Submit either electronic or written comments on the petitioner's environmental assessment by November 27, 2015. ADDRESSES: … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background DATES: Back to Top Submit either electronic or written comments on the supplemental proposed rule and related documents by October 23, 2015. ADDRESSES: Back to Top You may … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written/Paper Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Regulatory Authorities II. Regulatory History and Description of the Devices III. Proposed Regulation IV. Risks to Health A. Pediatric Medical Crib B. Medical Bassinet V. Establishment of Special Controls … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: Executive Summary Purpose of the Proposed Rule Summary of the Major Provisions of the Regulatory Action Costs and Benefits SUPPLEMENTARY INFORMATION: I. Background A. Definition of “Tobacco Product” B. Drug/Device/Combination Product Definitions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Format of the Public Meeting III. How To Participate in the Public Meeting IV. Transcripts and Recorded Video Tables Back to Top Table 1—Information on Participation in the Meeting … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Legal Authority III. Description of the Proposed Rule IV. Proposed Effective Date V. Economic Analysis of Impacts VI. Analysis of Environmental Impact VII. Paperwork Reduction Act of … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Charlotte Christin, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-3708. SUPPLEMENTARY INFORMATION: Back to Top In FR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Updated Information DATES: Back to Top We are extending the comment period that was scheduled to close on September 25, 2015, until October 13, 2015. ADDRESSES: Back … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is reopening the comment period on the notice of public hearing published March 27, 2015 (80 FR 16327), and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Description of the Proposed Rule A. Basis for the Designation of Distinguishable Names for Certain Biological Products 1. Safe Use 2. Pharmacovigilance 3. Additional Benefits of Consistent … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Requests for Comments and Information A. General Information About Submitting Comments B. Public Availability of Comments C. Information Identifying the Person Submitting the Comment DATES: Back to … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by September 14, 2015. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Comments III. References DATES: Back to Top The comment period for the proposed rule published March 3, 2014 (79 FR 11879), is reopened for the limited purpose … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action in Question Costs and Benefits I. Background A. NFL/SFL Proposed Rule B. Public Outreach … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. Introduction B. Accreditation of Third-Party Auditors Proposed Rule C. Regulatory Use of Certifications Under FSMA D. Reimbursement (User Fee) Program Under Section 808(c)(8) of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by August 17, 2015. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Proposed Rule Statement of Legal Authority Summary of the Major Provisions of the Proposed Rule Costs and Benefits I. Background II. Current Methods for Ensuring … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Requests for Comments and Information A. Nicotine Exposure Warnings B. Child-Resistant Packaging C. Other Actions and Considerations III. Comments A. General Information About Submitting Comments B. Public … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Listed Uses That May No Longer Be Considered Essential A. Sterile Aerosol Talc Administered Intrapleurally by Thoracoscopy for Human Use (21 CFR 2.125(e)(4)(ix)) B. Drug Products That … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is extending the comment period on the notice of public hearing published March 27, 2015 (80 FR 16327). Submit … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Significance of Guidance III. Paperwork Reduction Act of 1995 IV. Comments V. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of Proposed Rule Summary of Major Provisions Costs and Benefits I. Background II. Proposed Regulations A. Records and Reports—Conforming Changes (Proposed § 514.80(b)(4)(i)) B. Annual Sponsor Reports … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action in Question Effectiveness Safety Active Ingredients Costs and Benefits Table of Contents I. Introduction … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is extending the comment period on the proposed rule published February 6, 2015 (80 FR 6802). Submit either electronic … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on March 19, 2015. FOR FURTHER INFORMATION CONTACT: Back to Top Salome Bhagan, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. What is the background of this Proposed Rule? II. Why is FDA publishing this companion Proposed Rule? III. What is the legal authority for this Proposed Rule? IV. What … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Proposed Rule Summary of the Major Provisions of the Proposed Rule Costs and Benefits Table of Contents I. Background A. The Public Health Security and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background A. Homeopathic Products and the Federal Food, Drug, and Cosmetic Act B. Homeopathic Drugs and the OTC Drug Review C. FDA's Compliance Policy Guide D. Growth in the Sale of Drugs Labeled … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of § 176.170 DATES: Back to Top The food additive petition was filed on January 7, 2015. FOR FURTHER INFORMATION CONTACT: Back to Top Paul Honigfort, Center for Food Safety and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Amendment of 21 CFR 177.1210 III. Revocation of TOR Exemption No. 2005-006 IV. Issue of a New Regulation in 21 CFR 189 Subpart D V. Comments DATES: … [read more]

  Correction In Proposed Rule Document 2015-01666, pages 6801-6896, publishing in the Issue of Friday, February 6, 2015, make the following corrections: 1. On page 6807, in the second column in Table 1, the heading should read: Proposed Changes See section of this document (identified in parentheses) for more … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Request for Comments DATES: Back to Top FDA is extending the comment period on the proposed rule published on December 18, 2014 (79 FR 75506). Submit either … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. FY 2013 Regulatory Science Priorities III. FY 2014 Regulatory Science Priorities IV. FY 2015 Regulatory Science Priorities V. Purpose and Scope of the June 5, 2015, Public Hearing VI. Notice of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Regulatory Background A. Regulatory and Statutory Framework B. FDA's Review of Enzacamene II. Safety Data Considerations for OTC Sunscreen Products Containing Enzacamene A. Human Safety Data 1. Human Irritation, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Regulatory Background A. Regulatory and Statutory Framework B. FDA's Review of Ecamsule II. Safety Data Considerations for OTC Sunscreen Products Containing Ecamsule A. Human Safety Data 1. Human Irritation, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Registration and Requests for Oral Presentations III. Streaming Webcast of the Public Meeting IV. Comments V. Transcripts VI. Reference DATES: Back to Top Meeting. The public meeting … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits I. Background I.A. Hatch-Waxman Amendments I.B. Requirements for … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on December 22, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Ellen Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. How To Participate in the Public Meeting III. Comments, Transcripts, and Recorded Video IV. Reference Tables Back to Top Table 1—Information on Participation in the Meeting and … [read more]

  Correction FR proposed rule document 2015-00205 beginning on pages 1478 in the issue of Monday, January 12, 2015, was never placed on public inspection and was published in error. It should be removed. [FR Doc. C1-2015-00205 Filed 1-12-15; 4:15 pm] BILLING CODE 1505-01-D … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. How To Participate in the Public Meeting III. Comments, Transcripts, and Recorded Video IV. Reference Tables Back to Top Table 1—Information on Participation in the Meeting and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by February 5, 2015. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits I. Background II. Description of the Proposed Rule A. Current Exceptions … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action Costs and Benefits I. Background A. How do “Prescription Drug Labeling”, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: Back to Top Submit … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The proposed rule published July 2, 2014 (79 FR 37687) is corrected as of November 17, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Edisa Gozun, Center for Drug Evaluation and … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities A. Reclassification B. Requirement for Premarket Approval Application II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by December 8, 2014. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. How To Participate in the Public Meeting III. Comments, Transcripts, and Recorded Video Tables Back to Top Table 1—Information on Participation in the Meeting and on Submitting Comments to the Rulemaking … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Paperwork Reduction Act of 1995 III. Comments IV. Electronic Access DATES: Back to Top Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on September 22, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The color additive petition was filed on August 21, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Ellen Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by November 17, 2014. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition was filed on August 11, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Teresa A. Croce, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Supplemental Notice of Proposed Rulemaking Summary of the Revisions to the Proposed Rule Costs and Benefits I. Background A. Proposed Rule on … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Supplemental Notice of Proposed Rulemaking Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking Costs and Benefits I. Background … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking Costs and Benefits … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking Costs and Benefits … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device III. Device Description IV. Proposed Reclassification V. Risks to Health VI. Summary of Reasons for Reclassification VII. Summary of Data Upon … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device and the Device Description III. Proposed Reclassification and Summary of Reason for Reclassification IV. Risks to Health V. Summary of Data … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Withdrawal of the Proposed Rule III. Proposed Reclassification IV. Reference DATES: Back to Top The proposed rule is withdrawn on September 15, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Hina … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities II. Regulatory History of the Device A. EPPG Devices B. PSA Devices III. Device Description A. EPPG Devices B. PSA Devices IV. Proposed Reclassification A. EPPG Devices … [read more]

  Table of Contents Back to Top FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Back to Top Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: Back … [read more]

  Table of Contents Back to Top DATES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top The food additive petition and the citizen petition were withdrawn on July 30, 2014. FOR FURTHER INFORMATION CONTACT: Back to Top Molly A. Harry, Center for Food Safety and Applied Nutrition … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: Electronic Submissions Written Submissions FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Executive Summary Purpose and Coverage of the Proposed Rule Summary of the Major Provisions of the Proposed Rule Costs and Benefits I. Background II. Appropriate Controls Would Remain in Place … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Back to Top Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by September 22, 2014. ADDRESSES: Back to Top … [read more]

  Table of Contents Back to Top DATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: I. Background II. Purpose and Scope of the Public Hearing A. GDUFA Implementation: Draft Guidance Documents B. GDUFA Implementation Related to Generic Drug Exclusivity C. GDUFA Implementation and Potential First Generics III. Attendance, Registration, … [read more]

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