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- Documents
- Public Inspection
Topic
- Reporting and recordkeeping requirements 9
- Administrative practice and procedure 6
- Labeling 6
- Animal feeds 5
- Animal drugs 4
Section
- Health & Public Welfare 28
- Business & Industry 27
- Money 2
- World 1
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Type
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New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications (NADAs) for lack of compliance with the reporting requirements in an FDA regulation.
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New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.
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Securing Updated and Necessary Statutory Evaluations Timely
The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department's regulations have...
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Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is January 14, 2022.
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Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA or we) is establishing January 1, 2024, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2021, and on or before December 31, 2022. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of...
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The Use of an Alternate Name for Potassium Chloride in Food Labeling; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Use of an Alternate Name for Potassium Chloride in Food Labeling.'' This guidance explains our intent to exercise enforcement discretion for the declaration of the name ``potassium salt,'' as an alternative to ``potassium...
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Regulatory Clean Up Initiative; Correction
The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on November 16, 2020. This document had incorrectly designated footnotes and typographical errors.
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Regulatory Clean Up Initiative
The U.S Department of Health and Human Services (HHS) is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors. This document is necessary to inform the public of these non-substantive changes to HHS's regulations.
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The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.'' The guidance describes FDA's views on the declaration of allulose on Nutrition Facts and Supplement Facts labels and the caloric...
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Importation of Prescription Drugs
The Secretary of Health and Human Services (Secretary) is issuing a final rule to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit...
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Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction
The Food and Drug Administration (FDA, the Agency, or we) is correcting a final rule that published in the Federal Register of July 29, 2020. That final rule requires electronic submission of certain postmarketing safety reports for approved new animal drugs and provides a procedure for requesting a temporary waiver of the electronic submission...
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Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Correction
The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of August 13, 2020. The final rule establishes requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients.
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Revocation of the Test for Mycoplasma
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to remove the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive in that it...
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Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
The Food and Drug Administration (FDA or Agency) is providing notice of a stay of the effectiveness of provisions for devices in use on specific individuals who have or would need to obtain a physician- directed transition plan as of the date of publication on March 6, 2020, of the final regulation banning electrical stimulation devices (ESDs)...
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Office of Regulatory Affairs Division Director; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is revising its regulations to reflect changes to the Agency's organizational structure, including the reorganization of the Office of Regulatory Affairs (ORA). The revisions update addresses and replace references to the district officials with references to division officials. The rule...
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Veterinary Feed Directive Drugs; Contact Information
The Food and Drug Administration (FDA) is amending the animal drug regulations to revise a current mailing address and to add an email address to the previously codified contact information for use by distributors of an animal feed containing a veterinary feed directive (VFD) drug or a combination VFD drug. This technical amendment is being made...
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Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful...
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Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
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 chromium propionate.
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Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The final rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.
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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2020. FDA is informing the public of the availability of summaries of the basis of approval...