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

Results 401 - 450 of 29,744
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-06997
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2019-06996
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2019-06995
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-06994
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Modifications to Compliance Policy for Certain Deemed Tobacco Products; Extension of Comment Period
Document Number: 2019-06952
Type: Notice
Date: 2019-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled ``Modifications to Compliance Policy for Certain Deemed Tobacco Products'' that appeared in the Federal Register of March 14, 2019. In the draft guidance for industry, FDA requested comments on changes to the compliance policies for premarket review requirements for certain deemed tobacco products and how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Submission for OMB Review; Comment Request
Document Number: 2019-06945
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, Administration for Children and Families
Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-06900
Type: Notice
Date: 2019-04-08
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 Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Submission for OMB Review; Building Evidence on Employment Strategies for Low-Income Families (BEES) (New Collection)
Document Number: 2019-06898
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is proposing a data collection activity as part of the Building Evidence on Employment Strategies for Low-Income Families (BEES). The purpose of BEES is to evaluate the effectiveness of a broad range of innovative programs designed to boost employment and earnings among low-income Americans. Within this general focus area, ACF has a particular interest in programs that serve adults whose employment prospects have been affected by substance use disorder (SUD), opioid use disorder (OUD), mental health conditions, and justice involvement. ACF expects that a subset of programs to be evaluated will serve these specific target populations. To meet these objectives, this study will include impact and implementation evaluations for up to 21 sites, as well as descriptive work focused on other sites that have a focus on clients with opioid use and other substance abuse disorders. When possible, a randomized control trial research design will be used for the impact evaluations. The purpose of the current submission is to request approval for data collection needed for the BEES study.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-06896
Type: Notice
Date: 2019-04-08
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 Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-06884
Type: Notice
Date: 2019-04-08
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.
Availability of Draft Toxicological Profile for Glyphosate
Document Number: 2019-06832
Type: Notice
Date: 2019-04-08
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on the Draft Toxicological Profile for Glyphosate. On February 12, 2015 ATSDR announced that it was preparing to develop their Set 28 Draft Toxicological Profiles, including Glyphosate, for public comment release (80 FR 7870). All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile. ATSDR considers key studies for these substances during the profile development process. This document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Extension of Comment Period
Document Number: 2019-06819
Type: Proposed Rule
Date: 2019-04-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the notice of proposed rulemaking with comment entitled ``Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance'' that appeared in the February 4, 2019 Federal Register. The comment period for the proposed rule, which would end on April 5, 2019, is extended 60 days.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06816
Type: Notice
Date: 2019-04-08
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 Sealant Efficiency Assessment for Locals and States. This data will be collected from local school sealant programs to generate efficiency performance measures, which will allow CDC to identify feasible benchmarks and best practices contributing to school sealant program efficiency.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06815
Type: Notice
Date: 2019-04-08
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 ``National Disease Surveillance ProgramI. Case Reports'' to collect disease-specific surveillance reports of four rare, uncommon, or infrequent diseases.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06814
Type: Notice
Date: 2019-04-08
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 Stakeholder Interviews for the Evaluation of the World Trade Center Health Program (WTCHP) for Impact Assessment and Strategic Planning for Translational Research. This project will hold a series of semi-structured interviews with members of different stakeholder groups to explore their perspectives on the translational research mission of the WTCHP, including the use of research to improve care for members and impact on key program outcomes.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06813
Type: Notice
Date: 2019-04-08
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 Verona Integron-Encoded Metallo- [beta]-Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico. This project is being developed to identify infections among individuals in the U.S. who had surgery at Facility 1 in Tijuana, Mexico in order to prevent the spread of resistance in the U.S.
Mesothelioma Registry Feasibility; Request for Information
Document Number: 2019-06784
Type: Notice
Date: 2019-04-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), announces the opening of a docket to obtain information on the feasibility of a registry designed to track mesothelioma cases in the United States, as well as recommendations on enrollment, data collection, confidentiality, and registry maintenance. The purpose of such a registry would be to collect information that could be used to develop and improve standards of care and to identify gaps in mesothelioma prevention and treatment.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Evidence-Based Telehealth Network Program Measures, OMB No. 0906-xxxx-New
Document Number: 2019-06768
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
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 public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Assessing Care and Health Outcomes Among Ryan White HIV/AIDS Program (RWHAP) Clients Who Do Not Receive RWHAP-Funded Outpatient Ambulatory Health Services (OAHS), OMB No. 0906-xxxx-New
Document Number: 2019-06767
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
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 public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Health Center Program Forms, OMB No. 0915-0285-Revision
Document Number: 2019-06766
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
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 public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute of Neurological Disorders and Stroke
Document Number: 2019-06737
Type: Notice
Date: 2019-04-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-06736
Type: Notice
Date: 2019-04-05
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-day Comment Request: A Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Document Number: 2019-06735
Type: Notice
Date: 2019-04-05
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Risk Evaluation and Mitigation Strategy: The Food and Drug Administration's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary; Guidance for Industry; Availability
Document Number: 2019-06663
Type: Notice
Date: 2019-04-05
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 ``Risk Evaluation and Mitigation Strategy: FDA's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.'' This guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several developed to fulfill performance goals that FDA agreed to satisfy in the reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act (PDUFA) V). This guidance finalizes the draft guidance entitled ``FDA's Application of Statutory Factors in Determining When a REMS Is Necessary,'' issued September 21, 2016.
Determination That ANTIVERT Chewable Tablets, 25 Milligrams, and Tablets, 12.5 Milligrams, 25 Milligrams, and 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06656
Type: Notice
Date: 2019-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ANTIVERT (meclizine hydrochloride) chewable tablets, 25 milligrams (mg), and tablets, 12.5 mg, 25 mg, and 50 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Office of the Director; Notice of Charter Renewal
Document Number: 2019-06615
Type: Notice
Date: 2019-04-05
Agency: Department of Health and Human Services, National Institutes of Health
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT)
Document Number: 2019-06607
Type: Notice
Date: 2019-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC and the Health Resources and Services Administration (HRSA), announce the following meeting for the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). This meeting is open to the public, limited only by 90 seats and 70 ports for audio phone lines. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipts is Monday, May 13, 2019. Persons who desire to make an oral statement, may request it at the time of the public comments period on May 14, 2019 at 4:30 p.m., EDT.
Interagency Committee on Smoking and Health (ICSH); Notice of Charter Renewal
Document Number: 2019-06605
Type: Notice
Date: 2019-04-04
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 Interagency Committee on Smoking and Health, Department of Health and Human Services, has been renewed for a 2-year period through March 20, 2021.
Mine Safety and Health Research Advisory Committee (MSHRAC)
Document Number: 2019-06604
Type: Notice
Date: 2019-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at 412-386-5302 at least 5 business days in advance of the meeting.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2019-06602
Type: Notice
Date: 2019-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people and the audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).
Prospective Grant of an Exclusive/Co-Exclusive Patent License: Development and Commercialization of Next Generation Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like tyrosine kinase 3 (FLT3) Expressing Cancers
Document Number: 2019-06575
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
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/Co-Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Senti Bio (``Senti''), located in South San Francisco, CA.
Proposed Collection; 60-Day Comment Request; Scientific Information Reporting System (SIRS) (National Institute of General Medical Sciences)
Document Number: 2019-06572
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Cancer Institute; Notice of Meeting
Document Number: 2019-06571
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2019-06570
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Charter Renewal
Document Number: 2019-06569
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-06568
Type: Notice
Date: 2019-04-04
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: 2019-06567
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs
Document Number: 2019-06565
Type: Notice
Date: 2019-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
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; Proposed Collection; Comment Request; Guidance: Emergency Use Authorization of Medical Products and Related Authorities
Document Number: 2019-06553
Type: Notice
Date: 2019-04-04
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 proposed extension of the collection of information related to emergency use authorizations by the Agency.
Determination That QVAR 40 and QVAR 80 (Beclomethasone Dipropionate HFA) Inhalation Aerosol, 40 Micrograms and 80 Micrograms, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06552
Type: Notice
Date: 2019-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 micrograms (mcg) and 80 mcg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 mcg and 80 mcg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories
Document Number: 2019-06551
Type: Notice
Date: 2019-04-04
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 information collections regarding medical device accessories requests.
Determination That CORTISPORIN (Hydrocortisone/Neomycin Sulfate/Polymyxin B Sulfate) Otic Solution, 10 Milligrams/Milliliter Hydrocortisone, 3.5 Milligrams Base/Milliliter Neomycin Sulfate, 10,000 Units/Milliliter Polymyxin B Sulfate, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06549
Type: Notice
Date: 2019-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10 milligrams (mg)/milliliter (mL) hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD); Notice of Meeting
Document Number: 2019-06455
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-06452
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-06451
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-06450
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-06440
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services
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.
The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products; Public Hearing; Request for Comments
Document Number: 2019-06438
Type: Proposed Rule
Date: 2019-04-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.
Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments
Document Number: 2019-06436
Type: Proposed Rule
Date: 2019-04-03
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 hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
National Institute on Aging Notice of Closed Meeting
Document Number: 2019-06421
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health