Department of Health and Human Services March 4, 2021 – Federal Register Recent Federal Regulation Documents
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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
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 the Republic of Guinea (Guinea) within 21 days prior to their entry or attempted entry into the United States. This Order is based on the CDC Director's determination that such passengers are at risk of exposure to Ebola virus and that their accurate and complete contact information is needed to protect the health of fellow travelers and United States communities.
Privacy Act of 1974; System of Records
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 sections of the System of Records Notice (SORN) and are fully explained in the ``Supplementary Information'' section of this notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Multiple Indications in Direct-to-Consumer Television Advertisements
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.
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
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.
Privacy Act of 1974; System of Records
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 and supporting documents to HHS in response to HHS rulemakings and other docketed proceedings. The modifications include changing the name of the system of records to HHS Correspondence, Comment, Customer Service, and Contact List Records.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
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 each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA regulations requiring the declaration of color additives on animal food labels.
Request for Nominations on Device Good Manufacturing Practice Advisory Committee
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 requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.
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
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 (ANDAs) for lorcaserin hydrochloride tablets, 10 mg and 20 mg.
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
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's procedures for early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants.
``Low Income Levels'' Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act
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.
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