Results 1 - 50 of 27,951
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2018-27043
Type: Notice
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that GAMIFANT (emapalumab-lzsg) Injection, manufactured by Novimmune S.A., meets the criteria for a priority review voucher.
Submission for OMB Review; Comment Request
Document Number: 2018-27041
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
Determination That IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-26975
Type: Notice
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for indocyanine green for injection, 10 mg/vial, 40 mg/vial, and 50 mg/vial if all other legal and regulatory requirements are met.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-26960
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-26959
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2018-26958
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry; Availability
Document Number: 2018-26957
Type: Notice
Date: 2018-12-13
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 final guidance for industry entitled ``Data Integrity and Compliance With Drug CGMP: Questions and Answers.'' The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance has been developed in response to an increase in findings of data integrity lapses in recent inspections. FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.
Impossible Foods, Inc.; Filing of Color Additive Petition
Document Number: 2018-26949
Type: Proposed Rule
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to provide for the safe use of soy leghemoglobin as a color additive in plant-based, non-animal derived ground beef analogue products.
Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
Document Number: 2018-26947
Type: Notice
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) 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.
Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-26900
Type: Notice
Date: 2018-12-12
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 and FDA staff entitled ``Biomarker Qualification: Evidentiary Framework.'' This draft guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, that added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Qualification of a biomarker is a determination that within the stated context of use, the biomarker can be relied on to have a specific interpretation and application in drug development and regulatory review.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26876
Type: Notice
Date: 2018-12-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Million Hearts[supreg] Hypertension Control Challenge, a program designed to identify clinical practices and health systems that have been successful in achieving high rates of hypertension control and to develop models for dissemination of successful strategies to control hypertension.
Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities
Document Number: 2018-26857
Type: Notice
Date: 2018-12-12
Agency: Department of Health and Human Services
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications
Document Number: 2018-26855
Type: Notice
Date: 2018-12-12
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 ``The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.'' This draft guidance is intended to provide answers to common questions about FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's interpretation of this statutory provision. FDA also invites comment on the preliminary list of approved new drug applications (NDAs) for biological products under the FD&C Act that will be deemed to be BLAs on the transition date.
Interpretation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
Document Number: 2018-26854
Type: Notice
Date: 2018-12-12
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 final guidance for industry entitled ``Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' This guidance describes FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the ``deemed to be a license'' provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are approved under the FD&C Act as of March 23, 2020. This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of the transition provision of the BPCI Act.
Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
Document Number: 2018-26853
Type: Notice
Date: 2018-12-12
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 final guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'' issued April 28, 2015.
New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability
Document Number: 2018-26852
Type: Notice
Date: 2018-12-12
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 ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document revises the draft guidance document entitled ``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' issued May 13, 2015, to provide new and revised Q&As.
Definition of the Term “Biological Product”
Document Number: 2018-26840
Type: Proposed Rule
Date: 2018-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines ``biological product'' to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms ``protein'' and ``chemically synthesized polypeptide.'' Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-26790
Type: Notice
Date: 2018-12-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Su-Chiao Kuo: Debarment Order
Document Number: 2018-26778
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Su-Chiao Kuo for a period of 3 years 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 Dr. Kuo was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Kuo was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Kuo failed to request a hearing. Dr. Kuo's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.
Submission for OMB Review; 30-Day Comment Request National Cancer Institute (NCI) Future Fellows Resume Databank
Document Number: 2018-26765
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-26764
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services, National Institutes of Health
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-26760
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Nominations to the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2018-26756
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2018-26745
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces availability of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) Program, the Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), conducted a systematic review to evaluate the evidence of long-term neurological damage in humans after acute, sub-lethal exposure to sarin. The date for the peer review is not yet set; however, it is anticipated to occur in early 2019. The peer-review meeting will be held by webcast only and open to the public; registration will be required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.
The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments
Document Number: 2018-26725
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``FDA's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.'' Stakeholders, including healthcare providers (HCPs) and medical specialty groups, have expressed concerns regarding the availability of certain compounded drug products from outsourcing facilities that they would like to have on-hand as in-office supplies of non-patient-specific compounded drugs (``office stock''). The purpose of the public meeting is to provide HCPs, outsourcing facilities, entities considering becoming outsourcing facilities, and other interested parties with an opportunity to present to FDA their perspectives concerning access to office stock from outsourcing facilities in light of FDA's enforcement policies as proposed in the revised draft guidance on current good manufacturing practice (CGMP) for human drug compounding outsourcing facilities.
Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability
Document Number: 2018-26724
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Current Good Manufacturing PracticeGuidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.
David J. Fishman: Debarment Order
Document Number: 2018-26722
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman for a period of 3 years 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 Dr. Fishman was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
The Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2018-26721
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (the 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.
List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
Document Number: 2018-26712
Type: Rule
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.
Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities; Request for Information
Document Number: 2018-26708
Type: Notice
Date: 2018-12-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; help current smokers quit; and identify and eliminate tobacco-related disparities. In late 2017, CDC solicited input from the public in the Federal Register Notice 82 FR 50428 regarding nationwide priorities for cessation. CDC is currently reviewing and compiling public comments to inform future activities that could efficiently and cost effectively help people quit using tobacco by employing evidence-based treatment options. CDC will share the outcome of this request for information with the public on a date to be determined. Now, CDC is seeking information to inform future activities to advance tobacco control practices that prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-26676
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2018-26675
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2018-26674
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2018-26673
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-26672
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2018-26671
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Amended Notice of Meeting
Document Number: 2018-26670
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-26659
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26637
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Application for Training (OMB Control No. 0920-0017). The Training and Continuing Education Online (TCEO) system is used in the management of the accreditation process for non-federal educators who develop public health and healthcare educational activities and for non-federal health professionals who seek continuing education necessary to maintain professional licensures and certifications. This request for revision is to add new questions to the TCEO New Participant Registration, a new TCEO Post-Course Evaluation, and a new TCEO Follow-up Evaluation. Both new evaluation tools will improve the quality of educational activities. Each TCEO tool ensures compliance with accreditation requirements.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26636
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Understanding How Discounting Affects Decision Making and Adoption of Prevention Through Design Solutions. The goal of this information collection is to understand the social and organizational factors that may increase or decrease the adoption of practices that keep workers safe.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26635
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comments on a proposed information collection project titled ``Online training for law enforcement to reduce risks associated with shift work and long work hours''. This study will develop and pilot test a new, online, interactive training program tailored for the law enforcement community that relays the health and safety risks associated with shift work, long work hours, and related workplace sleep issues, and presents strategies for managers and officers to reduce these risks.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-26634
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-26633
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-26626
Type: Notice
Date: 2018-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee (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. FDA is establishing a docket for public comment on this document.
National Eye Institute; Notice of Meeting
Document Number: 2018-26596
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Patient Protection and Affordable Care Act; Adoption of the Methodology for the HHS-Operated Permanent Risk Adjustment Program for the 2018 Benefit Year Final Rule
Document Number: 2018-26591
Type: Rule
Date: 2018-12-10
Agency: Department of Health and Human Services
This final rule adopts the HHS-operated risk adjustment methodology for the 2018 benefit year. In February 2018, a district court vacated the use of statewide average premium in the HHS-operated risk adjustment methodology for the 2014 through 2018 benefit years. Following review of all submitted comments to the proposed rule, HHS is adopting for the 2018 benefit year an HHS-operated risk adjustment methodology that utilizes the statewide average premium and is operated in a budget-neutral manner, as established in the final rules published in the March 23, 2012 and the December 22, 2016 editions of the Federal Register.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2018-26568
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding a meeting and will discuss recommendations regarding programs, policies, and research to promote effective, prevention, treatment and cure of HIV disease and AIDS. The meeting will be open to the public.
Submission for OMB Review; Head Start Child and Family Experiences Survey (FACES) (OMB #0970-0151)
Document Number: 2018-26563
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new round of the Head Start Family and Child Experiences Survey (FACES).
Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information
Document Number: 2018-26561
Type: Notice
Date: 2018-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain data, information, and comments that will assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the- counter (OTC) human use. We are asking manufacturers of food handler antiseptics and other interested parties to submit safety and effectiveness data on OTC food handler antiseptics marketed for use by food handlers in commercial or regulated environments where growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service, or consumption of food occurs. We also are inviting comments and requesting data on definitions, eligibility, current conditions of use of food handler antiseptics; safety and effectiveness criteria; as well as test methods to demonstrate the effectiveness of food handler antiseptics. In general, we are seeking input on current use conditions of antiseptics used in the food handler setting and recommended testing to establish the effectiveness of OTC food handler antiseptics. This information and data will inform FDA's ongoing review of OTC antiseptic drug products and will specifically inform our review of food handler antiseptic products.
Laboratory Animal Welfare: Draft Report on Recommendations To Reduce Administrative Burden on Researchers
Document Number: 2018-26557
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) is seeking input on the draft report by the 21st Century Cures Act Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. The draft report is a coordinated effort of the Director of the National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs. It describes the proposed actions that the working group has identified to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.