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Publication date
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Type
- Notice 18
- Proposed Rule 2
Topic
- Privacy 1
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Agency
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Implementation of Executive Order on Access to Affordable Life-Saving Medications; Delay of Effective Date
In accordance with the Presidential directive as expressed in the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action proposes, following a 5-day public comment period, to further delay until July 20, 2021, the effective date of the rule entitled...
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Government-Owned Inventions; Availability for Licensing
The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of sublicensable patent licenses to Simon Fraser University (``Simon Fraser''), a non-profit university located in British Columbia, Canada, and Le Centre National de la Recherche Scientifique...
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Prospective Grant of an Exclusive Patent License: Engineered Tumor Infiltrating Lymphocytes for Cancer Therapy
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Iovance Biotherapeutics,...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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...
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Agency Information Collection Activities: Public Comment Request; Information Collection Request Title: Health Professions Student Loan Program, Loans for Disadvantaged Students, Primary Care Loan Program, and Nursing Student Loan Program Administrative Requirements. OMB No. 0915-0047-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA 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...
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Agency Information Collection Activities: Proposed Collection: Comment Request; Information Collection Request Title: Survey of Eligible Users of the National Practitioner Data Bank, OMB No. 0915-0366-Reinstatement With Change
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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...
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Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
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Notice of Availability of a Draft Policy Statement for the Biosafety of Large Animal Study-Related Activities With Brucella abortus and Brucella suis Using Outdoor Containment Spaces
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is opening a public docket to obtain comment on a draft Brucella policy statement. This draft policy statement, when finalized, will aid individuals and entities in the development of biosafety plans for outdoor large animal studies...
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information...
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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 is updating and renaming an existing system of records maintained by the National Institutes of Health (NIH), 09-25-0165, ``National Institutes of Health (NIH) Office of Loan Repayment and Scholarship (OLRS) Record System,...
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Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department) proposes to exempt confidential source identifying information in a system of records maintained by the National Institutes of Health (NIH) from certain requirements of the Privacy Act. The affected system of records is 09-25-0165, ``National Institutes of Health (NIH) Office of...
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Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information
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,...
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Proposed Revised Vaccine Information Materials
Under the National Childhood Vaccine Injury Act (NCVIA), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written...
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Information for Participation in the Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
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...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
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...
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Determination of Regulatory Review Period for Purposes of Patent Extension; TAKHZYRO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TAKHZYRO 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,...
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Determination of Regulatory Review Period for Purposes of Patent Extension; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM (EVERSENSE CGM 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....