Requirement for Airlines To Collect Designated Information for Passengers Destined for the United States Who Are Departing From, or Were Otherwise Present in the Democratic Republic of the Congo or the Republic of Guinea

by the Centers for Disease Control and Prevention on 03/04/2021.

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of an Order requiring airlines and aircraft operators to collect designated information for passengers who are departing from, or were otherwise present in, the Democratic Republic of the Congo (DRC) or...

Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use

by the Food and Drug Administration on 03/04/2021.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information,...

Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives

by the Food and Drug Administration on 03/04/2021.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including...

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Obtaining Information To Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities

by the Food and Drug Administration on 03/04/2021.

The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ``Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Multiple Indications in Direct-to-Consumer Television Advertisements

by the Food and Drug Administration on 03/04/2021.

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.

Request for Nominations on Device Good Manufacturing Practice Advisory Committee

by the Food and Drug Administration on 03/04/2021.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also...

Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10 Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release Tablets, 20 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness

by the Food and Drug Administration on 03/04/2021.

The Food and Drug Administration (FDA or Agency) has determined that BELVIQ (lorcaserin hydrochloride) tablets, 10 milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended- release tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications...

``Low Income Levels'' Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act

by the Health Resources and Services Administration on 03/04/2021.

HRSA is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act.

Privacy Act of 1974; System of Records

by the Health and Human Services Department on 03/04/2021.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying a department-wide system of records titled HHS Correspondence, Customer Service, and Contact List Records, system no. 09-90-1901, to make certain updates and to more clearly include records about individuals who provide comments...

Privacy Act of 1974; System of Records

by the National Institutes of Health on 03/04/2021.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is publishing notice of modifications to a system of records maintained by the National Institutes of Health (NIH), ``Clinical Research: Patient Medical Records, HHS/NIH/CC,'' no. 09-25-0099. The modifications affect most...

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice for Manufacturing, Processing, Packing, and Holding of Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed extension of an existing...

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Study of How Consumers Use Flavors To Make Inferences About Electronic Nicotine Delivery System Product Qualities and Intentions To Use (Phase 2)

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow...

Proposal To Refuse To Approve a New Drug Application for Sotagliflozin Oral Tablets, 200 Milligrams and 400 Milligrams; Opportunity for a Hearing

by the Food and Drug Administration on 03/03/2021.

The Director of the Center for Drug Evaluation and Research (Center Director) of the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Lexicon Pharmaceuticals, Inc. (Lexicon) for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. This notice...

Michael Gurry: Final Debarment Order

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Michael Gurry from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Gurry was convicted of a felony...

PolyMedica Industries Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three new drug applications (NDAs) and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file...

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 054

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 054''...

Lawrence B. Ryan: Final Debarment Order

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Lawrence B. Ryan from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Ryan was convicted of a...

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and Drug Administration Regulated Products

by the Food and Drug Administration on 03/03/2021.

The Food and Drug Administration (FDA or Agency) 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 (PRA).

National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

by the National Institutes of Health on 03/03/2021.