Department of Health and Human Services April 1, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
TG United, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of January 15, 2021. The document announced the withdrawal of approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants as of February 16, 2021. The document indicated that FDA was withdrawing approval of the following three ANDAs after receiving a withdrawal request from Upsher- Smith Laboratories, LLC., 6701 Evenstad Dr., Maple Grove, MN 55369: ANDA 084041, Chlordiazepoxide Hydrochloride (HCl) Capsules, 10 milligrams (mg); ANDA 084678, Chlordiazepoxide HCl Capsules, 5 mg; and ANDA 084679, Chlordiazepoxide HCl Capsules, 25 mg. Before FDA withdrew the approval of these ANDAs, Upsher-Smith Laboratories, LLC., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Upsher-Smith Laboratories, LLC., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 084041, 084678, and 084679 is still in effect. In addition, the document indicated that FDA was withdrawing approval of ANDA 206061, Pravastatin Sodium Tablets, 20 mg, 40 mg, and 80 mg, after receiving a request from Hisun Pharmaceutical (Hangzhou) Co., Ltd. However, the document published with the incorrect applicant name for ANDA 206061. This document corrects that error. All other information for ANDA 206061 remains the same.
Proposed Information Collection Activity; Public Comment Request; Extension of a Currently Approved Information Collection; State Developmental Disabilities Council-Annual Program Performance Report (PPR) (OMB Control Number 0985-0033)
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to extend the use of the current PPR data collection necessary to determine grantee compliance with Part B of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act). Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the proposed action. This notice solicits comments on a proposed extension to an existing data collection related to the State Councils on Developmental Disabilities (State Councils) Annual Program Performance Report (PPR). On an annual basis, each Council must submit a PPR to describe the extent to which annual progress is being achieved on the 5-year State plan goals. The PPR will be used by: (1) The Council as a planning document to track progress made in meeting state plan goals; (2) the citizenry of the State as a mechanism for monitoring progress and activities on the plans of the Council; and (3) the Department as a stewardship tool for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act and for monitoring and providing technical assistance (e.g., during site visits), and support for management decision making.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; National Survey of Older Americans Act Participants
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the information collection requirements for consumer assessment surveys used by ACL to measure program performance for programs funded under Title III of the Older Americans Act. This notice solicits comments on a proposed revision of a currently approved collection with the addition of a new rotating module to the National Survey of Older Americans Act Participants.
Determination That SERENTIL (Mesoridazine Besylate) Tablets, 10 Milligrams, 25 Milligrams, 50 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, the Agency, or we) has determined that SERENTIL (mesoridazine besylate) tablets, 10 milligrams (mg), 25 mg, 50 mg, and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mesoridazine besylate tablets, 10 mg, 25 mg, 50 mg, and 100 mg, if all other legal and regulatory requirements are met.
Determination That CUTIVATE (Fluticasone Propionate) Ointment, 0.005 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that CUTIVATE (fluticasone propionate) ointment, 0.005 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to NovaSterilis, Inc. for the Nova2200 using the NovaClean decontamination process. FDA revoked the Authorization on February 12, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Determination of Regulatory Review Period for Purposes of Patent Extension; BIOMIMICS 3D VASCULAR STENT SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIOMIMICS 3D VASCULAR STENT SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Food and Drug Administration Science Forum 2021; Public Workshop
The Food and Drug Administration (FDA, Agency, or we) is announcing the following virtual public workshop entitled ``FDA Science Forum 2021.'' The purpose of the public workshop is to inform the public about the groundbreaking science conducted at the Agency and to show how scientific research is used in FDA's regulatory decisions to protect and promote public health.
New Animal Drugs; Approval of New Animal Drug Applications
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 October, November, and December 2020. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
Determination of Regulatory Review Period for Purposes of Patent Extension; TPOXX
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for TPOXX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Determination of Regulatory Review Period for Purposes of Patent Extension; IBSRELA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IBSRELA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request; Federal Tort Claims Act Program Deeming Applications for Health Centers, 0906-0035, Extension
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
Medical Devices; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete office with updated information. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Electronic Import Entries; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The present revisions are necessary to correct editorial errors and to ensure that the codified cites the correct section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The electronic import entries regulation provides that the Drug Registration Number, which must be submitted at the time of entry in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), is the unique facility identifier specified in the FD&C Act. This rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections
On August 31, 2016, the Food and Drug Administration (FDA or Agency) published an amended final rule that listed inaccurate cross- references to FDA's drug establishment registration and drug listing regulations. This document corrects the inaccurate cross-references used in the final regulations.
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