Department of Health and Human Services September 2019 – Federal Register Recent Federal Regulation Documents
Results 201 - 249 of 249
Humanitarian Device Exemption Program; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Humanitarian Device Exemption Program.'' This guidance concerns the humanitarian device exemption (HDE) program as a whole and, among other topics, it explains the criteria FDA considers to determine if ``probable benefit'' has been demonstrated as part of the Agency's decision-making process regarding marketing authorization for a humanitarian use device (HUD). The guidance also reflects recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that affect the HDE program and answers common questions that we receive about the program.
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on the ACHDNC website at: https://www.hrsa.gov/advisory-committees/ heritable-disorders/.
Intent To Award a Single-Source Supplement for the Centers for Independent Living (Subchapter C) Training & Technical Assistance (T&TA) Center Cooperative Agreement
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Memorial Hermann Health System for training and technical assistance to the Centers for Independent Living (CILs) that are Subchapter C grantees. The purpose of this project is to develop and provide trainings for CILs, develop and provide TA to CILs, administer peer mentoring for CILs, and refer CILs to other T&TA resources. The administrative supplement for FY 2019 will be in the amount of $351,327, bringing the total award for FY 2019 to $1,634,490.
Agency Information Collection Activities: Proposed Collection: Comment Request; Information Request Title: 340B Drug Pricing Program Reporting Requirements, OMB Number 0915-0176-Extension
In compliance with the requirement for opportunity for public comment on proposed data collection, the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Determination of Regulatory Review Period for Purposes of Patent Extension; SHINGRIX
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SHINGRIX 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug-Patent Submission and Listing Requirements
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 for Industry on E6(R2) Good Clinical Practice; International Council for Harmonisation; Integrated Addendum to International Council for Harmonisation E6(R1)
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection recommendations found in Agency guidance pertaining to the development of a system to manage quality as well as information to include in a clinical study report about the quality management approach.
Determination of Regulatory Review Period for Purposes of Patent Extension; GIAPREZA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GIAPREZA 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 drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Pilot Program
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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.
The National Institutes of Health (NIH) Sexual & Gender Minority Research Listening Session
The National Institutes of Health (NIH) Sexual & Gender Minority Research Office (SGMRO) will be holding a listening session with the Sexual & Gender Minority (SGM) community. The primary objectives of the NIH's listening session are: (1) To hear from community stakeholders about what issues are on their minds with regard to SGM-related research and related activities at the NIH, and (2) to use these individual viewpoints to help inform the development of the NIH SGM Research FY 2021-2025 strategic plan. The goal is to hold a listening session every year, to provide different SGM focused organizations an opportunity to join a session in person.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Performance Monitoring of Working with Publicly Funded Health Centers to Reduce Teen Pregnancy among Youth from Vulnerable Populations (OMB Control No. 0920-1156, Exp. 01/ 30/2020). A Revision is requested to continue collecting data through the end of the funding period and to develop systematic approaches to referring youth at risk for a teen pregnancy to reproductive health care.
Amendments to the List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or Agency) has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. This proposed rule would amend that list by placing five additional bulk drug substances on the list. This proposed rule also identifies 26 bulk drug substances that FDA has considered and proposes not to include on the list. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting.
General Hospital and Personal Use Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee (the 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; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications
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.
Meeting of the Advisory Committee on Training in Primary Care and Dentistry
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care and Dentistry (ACTPCMD) has scheduled a public meeting. Information about ACTPCMD and the agenda for this meeting can be found on the ACTPCMD website at: https://www.hrsa.gov/advisory-committees/ primarycare-dentist/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 request for extension of an approved information collection titled Emergency Epidemic Investigation Data Collections (OMB Control No. 0920-1011). CDC will use the information collected to identify prevention and control measures in response to outbreaks and other public health events.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Diabetes Prevention Program (DPP) Introductory Session Project. This information collection aims to help CDC determine the prevalence and types of introductory sessions being offered as a recruitment strategy to increase enrollment in the National Diabetes Prevention Program lifestyle change program (National DPP LCP) (Phase 1: Introductory Session Landscape Assessment) and to evaluate a behaviorally-focused intervention known as Be Your Best (BYB) Discovery Session compared with other already occurring introductory sessions.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 CDC Oral Health Management Information System. The collection aims to monitor the performance of states funded to implement evidence-based prevention strategies to improve oral health, determine and tailor technical assistance to the states, and share quality improvement findings.
Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
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 collection associated with safe and sanitary processing and importing of fish and fishery products.
Meeting of the National Clinical Care Commission
The National Clinical Care Commission (the Commission) will conduct a virtual meeting on September 27, 2019. The Commission is charged to evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns
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.
List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies nine bulk drug substances that FDA has considered and is proposing not to include on the list: Dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of August 2, 2019. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.
Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients (``Draft Guideline''). The Draft Guideline provides new, evidence-based recommendations specific to the prevention and control of Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA) and methicillin- sensitive S. aureus (MSSA), in neonatal intensive care unit (NICU) patients.
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