Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache
Document Number: 2018-22842
Type: Rule
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the thermal vestibular stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the thermal vestibular stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System
Document Number: 2018-22840
Type: Rule
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the positive airway pressure delivery system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the positive airway pressure delivery system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device
Document Number: 2018-22837
Type: Rule
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
Document Number: 2018-22821
Type: Notice
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 ``Application for Participation in FDA Fellowship and Traineeship Programs.''
Determination of Regulatory Review Period for Purposes of Patent Extension; IMFINZI
Document Number: 2018-22806
Type: Notice
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMFINZI 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 biological product.
Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications
Document Number: 2018-22805
Type: Notice
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application
Document Number: 2018-22786
Type: Rule
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the light based energy source device for topical application into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the light based energy source device for topical application's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms
Document Number: 2018-22785
Type: Rule
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the intranasal electrostimulation device for dry eye symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intranasal electrostimulation device for dry eye symptoms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use
Document Number: 2018-22784
Type: Rule
Date: 2018-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemostatic device for intraluminal gastrointestinal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
National Heart, Lung, and Blood Institute Notice of Closed Meetings
Document Number: 2018-22760
Type: Notice
Date: 2018-10-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-NEW)
Document Number: 2018-22754
Type: Notice
Date: 2018-10-19
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the 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 notice. This New Data Collection (ICR New) solicits comments on the information collection requirements relating to the Centers for Independent Living under the Rehabilitation Act of 1973.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; the State Plan for Independent Living (SPIL) (0985-0044)
Document Number: 2018-22753
Type: Notice
Date: 2018-10-19
Agency: Department of Health and Human Services
The Administration for Community Living is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the 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 notice. This Extension Without Changes (Information Collection Request Ext) solicits comments on the information collection requirements related to the State Plan for Independent Living (SPIL) required under the Rehabilitation Act of 1973, as amended. The Independent Living Administration within ACL is proposing to extend the currently approved forms for one year while we work on a revision. However, we expect to complete the redesign of the proposed information collection forms well before the expiration of the extension.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Independent Living Services Program Performance Report (0985-0043)
Document Number: 2018-22751
Type: Notice
Date: 2018-10-19
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the 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 notice. This proposed Extension with Changes of a Currently Approved Collection (ICR Rev) solicits comments on the information collection requirements relating to the Independent Living Services (ILS) program under the Rehabilitation Act of 1973, 29 U.S.C. 701, et seq.
Posting of the National Security Presidential Memorandum 14, “Support for National Biodefense”
Document Number: 2018-22742
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, Office of the Secretary
National Security Presidential Memorandum 14 directs
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22725
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2018-22724
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2018-22723
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing; Correction
Document Number: 2018-22722
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National
Partnership Opportunity To List in a Public Database (PPE-Info) Appropriate Personnel Protective Equipment Products That Protect Workers Against Fentanyl Exposure
Document Number: 2018-22721
Type: Notice
Date: 2018-10-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of
Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision
Document Number: 2018-22708
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public
Proposed Information Collection Activity; Comment Request
Document Number: 2018-22700
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, Administration for Children and Families
Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS
Document Number: 2018-22699
Type: Notice
Date: 2018-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has
Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency
Document Number: 2018-22698
Type: Proposed Rule
Date: 2018-10-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise the Federal Health Insurance
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-22697
Type: Notice
Date: 2018-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing
Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA
Document Number: 2018-22696
Type: Notice
Date: 2018-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22680
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2018-22679
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2018-22678
Type: Notice
Date: 2018-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Neurological Devices; Classification of the External Upper Limb Tremor Stimulator
Document Number: 2018-22695
Type: Rule
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the external upper limb tremor stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external upper limb tremor stimulator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel
Document Number: 2018-22694
Type: Rule
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-22634
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22632
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2018-22631
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2018-22629
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-22623
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-22622
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-22621
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-22620
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2018-22619
Type: Notice
Date: 2018-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP); Notice of Charter Renewal
Document Number: 2018-22616
Type: Notice
Date: 2018-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through September 18, 2020.
Isachi Gil; Denial of Hearing; Final Debarment Order
Document Number: 2018-22581
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying Isachi Gil's (Gil's) request for a hearing and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Gil for 6 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Gil was convicted of 12 felonies under Federal Law involving fraud or falsification and that Gil has demonstrated a pattern of conduct sufficient to find that there is reason to believe she may violate requirements under the FD&C Act relating to drug products. In determining the appropriateness and period of Gil's debarment, FDA considered the relevant factors listed in the FD&C Act. Gil failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
Document Number: 2018-22578
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
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 guidance for industry entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.''
Determination of Regulatory Review Period for Purposes of Patent Extension; TREMFYA
Document Number: 2018-22571
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TREMFYA 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 biological product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of an Accelerated Approval Disclosure
Document Number: 2018-22570
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Experimental Study of an Accelerated Approval Disclosure.'' This study will examine the presence, wording, and prominence of a disclosure communicating information related to the drug's accelerated approval in direct-to- consumer (DTC) promotional materials.
Agency Information Collection Activities; Proposed Collection; Comment Request; Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces
Document Number: 2018-22569
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces.'' This study will examine important public health issues in professionally directed prescription drug print promotion.
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Draft Guidance for Industry; Availability
Document Number: 2018-22568
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.'' This draft guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs and in DTC promotional labeling for over-the- counter (OTC) animal drugs (collectively promotional materials). FDA is issuing this draft guidance to describe the Agency's recommendations for how manufacturers, distributers, and packers (collectively firms) that include quantitative efficacy or risk information about their drugs in DTC promotional materials can make the language and presentation more consumer-friendly.
Agency Information Collection Activities; Proposed Collection; Comment Request; Disease Awareness and Prescription Drug Promotion on Television
Document Number: 2018-22567
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Disease Awareness and Prescription Drug Promotion on Television.''
Determination of Regulatory Review Period for Purposes of Patent Extension; DUPIXENT
Document Number: 2018-22566
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DUPIXENT 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 biological product.
Oncology Center of Excellence: Pediatric Oncology Program; Establishment of a Public Docket; Request for Comments
Document Number: 2018-22565
Type: Notice
Date: 2018-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Oncology Center of Excellence (OCE) Pediatric Oncology Program of the Food and Drug Administration (FDA or the Agency) announces the creation of a list of molecular targets that have been determined to be substantially relevant to the growth or progression of a pediatric cancer (Candidate Pediatric Molecular Target List) and a list of molecular targets of new cancer drugs and biological products in development for which requirements for studies in pediatric cancers would be automatically waived. The former list includes molecular targets for which prevailing evidence and/or a scientific rationale exists to determine their potential relevance to the growth or progression of one or more pediatric cancers. The latter list details those targets that are unlikely to be associated with the growth or progression of pediatric cancers such that statutory requirements for early pediatric evaluation would be waived. These lists fulfill one of FDA's obligations under the FDA Reauthorization Act of 2017 (FDARA) and provide information to industry in planning for initial pediatric study plan submissions for certain oncology drugs or biological products in accordance with the amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is establishing this docket for public comment on possible additions to or deletions from the list on the lists described above. The lists can be found on the Oncology Center of Excellence: Pediatric Oncology website at the following link: https://www.fda.gov/ AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE / ucm544641.htm.
Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC); Notice of Charter Renewal
Document Number: 2018-22561
Type: Notice
Date: 2018-10-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through September 12, 2020.