Department of Health and Human Services September 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 283
Vaccines and Related Biological Products Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This meeting was announced in the Federal Register of August 28, 2020. The amendment is being made to reflect changes in the ADDRESSES portion of the document.
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic PotentialQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance contains revised questions and answers (Q&As) for the ICH guidance for industry ``E14 Clinical Evaluation of the QT/ QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs'' and new Q&As for the ICH guidance for industry ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals'' that provide recommendations on considerations for an integrated risk assessment combining nonclinical and clinical datain particular, at later stages of drug development when clinical data are available. The draft guidance is intended to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision making.
Patient-Focused Drug Development for Stimulant Use Disorder; Public Meeting; Request for Comments
In the Federal Register notice published on March 19, 2020, the Food and Drug Administration (FDA, the Agency, or we) announced the cancellation of the meeting entitled ``Patient-Focused Drug Development for Stimulant Use Disorder'' originally scheduled to occur on March 10, 2020, as announced in the Federal Register on February 18, 2020. FDA is announcing a new date for the meeting, to occur in a virtual format. The purpose of the public meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder.
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 Strengthening U.S. Response to Resistant Gonorrhea, which is to intended to enhance U.S. state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea (an urgent public health threat), and advance the understanding of epidemiological factors contributing to antibiotic-resistant gonorrhea. CDC is requesting a three-year approval.
Availability of Draft Toxicological Profile for Ethylene Oxide
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 Ethylene Oxide.
Submission for OMB Review; National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (NAC) Recommendations and State Self-Assessment Survey (NEW)
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new survey, the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (NAC) Recommendations and State Self- Assessment Survey.
Notice To Announce Supplemental Awards To Support Training and Technical Assistance To Address Intimate Partner Violence
HRSA provided supplemental funding to two current National Training and Technical Assistance Partners award recipients to advance HRSA's Strategy to Address Intimate Partner Violence by expanding critical training and technical assistance (T/TA) to health centers.
Collection of Certain Data Regarding Passengers and Crew Arriving From Foreign Countries by Airlines; Rescission of Agency Order
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the rescission of an Agency Order that was published in the Federal Register on February 24, 2020.
Notice To Announce Supplemental Award To Support Training and Technical Assistance To Address Clinical Workforce Development
HRSA provided supplemental funding to Community Health Center, Inc. (CHCI), a currently-funded National Training and Technical Assistance Partner (NTTAP) award recipient. CHCI will expand training and technical assistance (T/TA) to health centers and HRSA-funded State and Regional Primary Care Associations (PCAs) to support implementation of a tool developed for health centers to assess and improve their readiness to engage in health professional training programs and address national health care workforce shortages.
Submission for OMB Review; National Survey of Early Care and Education COVID-19 Follow-Up (OMB #0970-0391)
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a two-wave data collection as part of the National Survey of Early Care and Education (NSECE) (OMB #0970-0391), which will be conducted October 2020 through June 2021. The objective of the NSECE COVID-19 Follow-up is to document the nation's current supply of early care and education (ECE) services that is home-based providers, center-based providers, and the center-based provider workforce. In the context of the COVID-19 pandemic, the NSECE COVID-19 Follow-up will deepen our understanding of the state of ECE supply and the ECE workforce following the initial period of crisis, including changes in supply or departures from and re-entries to the workforce.
Abbreviated New Drug Application Submissions-Amendments and Requests for Final Approval To Tentatively Approved Abbreviated New Drug Applications; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA SubmissionsAmendments and Requests for Final Approval to Tentatively Approved ANDAs.'' This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (earliest lawful approval date). This guidance finalizes the draft guidance of the same title issued on February 1, 2019.
Failure To Respond to an Abbreviated New Drug Application Complete Response Letter Within the Regulatory Timeframe; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.'' This guidance is intended to assist applicants in responding to complete response letters (CRLs) to abbreviated new drug applications (ANDAs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act. This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL as well as the actions that FDA may take if the applicant fails to respond to a CRL. In addition, this guidance recommends information an applicant may submit in its request for an extension to respond to a CRL as well as a non-exhaustive list of factors that FDA will consider in determining whether such a request is reasonable.
Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2022.
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; 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 ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use.
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of the final guidance entitled ``Self- Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' This guidance described studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs), which are for over-the-counter (OTC) home use by lay users. This guidance is not meant to address blood glucose monitoring test systems (BGMS) that are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long-term care facilities).
M7 Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic RiskQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk. Since the ICH M7 Guideline was finalized, the worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities. To facilitate the implementation of the ICH M7 Guideline, the ICH M7 Implementation Working Group has developed a series of questions and answers (Q&As). The scope of this draft Q&A guidance follows that of the ICH M7 Guideline. The draft Q&A guidance is intended to clarify, promote the convergence of, and improve the harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided when developing drugs, completing marketing authorization applications, and using drug master files.
Roerig Division of Pfizer Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 21, 2020. The document announced the withdrawal of approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 20, 2020. The document indicated that FDA was withdrawing approval of the following two ANDAs after receiving a withdrawal request from Kadmon Pharmaceuticals, LLC., 119 Commonwealth Dr., Warrendale, PA 15086: ANDA 076203, Ribavirin Capsules, 200 milligrams (mg) and ANDA 077456, Ribavirin Tablets, 200 mg, 400 mg, and 600 mg. Before FDA withdrew the approval of these ANDAs, Kadmon Pharmaceuticals, LLC. informed FDA that it did not want the approval of the ANDAs withdrawn. Because Kadmon Pharmaceuticals, LLC., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 076203 and 077456 are still in effect.
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.'' Sponsors may encounter challenges in identifying methods to assess the numerous and heterogeneous Coronavirus Disease 2019 (COVID-19)-related symptoms across subjects when designing clinical trials of drugs to treat or prevent COVID-19 in adult and adolescent outpatient subjects. To assist sponsors, this guidance describes an example with a set of common COVID-19-related symptoms as well as an approach to their measurement for use in clinical trials. Given the public health emergency presented by COVID- 19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.
Advisory Committee; Blood Products Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 13, 2022, expiration date.
Breast Implants-Certain Labeling Recommendations To Improve Patient Communication; 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 ``Breast Implants Certain Labeling Recommendations to Improve Patient Communication.'' This guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel- filled breast implants. FDA is issuing this guidance to help ensure that a patient receives and understands the benefits and risks of breast implants. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of breast implants that uniquely pertain to individual patients.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
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 generic clearance for the collection of qualitative data on tobacco products and communications.
Peripheral and Central Nervous System Drugs 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 Peripheral and Central Nervous System 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.
Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
In accordance with the Federal Advisory Committee Act, this notice announces that the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting.
Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures
This final rule implements two new mandatory Medicare payment models under section 1115A of the Social Security Actthe Radiation Oncology Model (RO Model) and the End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model). The RO Model will promote quality and financial accountability for providers and suppliers of radiotherapy (RT). The RO Model will be a mandatory payment model and will test whether making prospective episode payments to hospital outpatient departments (HOPD) and freestanding radiation therapy centers for RT episodes of care preserves or enhances the quality of care furnished to Medicare beneficiaries while reducing Medicare program spending through enhanced financial accountability for RO Model participants. The ETC Model will be a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants, in order to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures. The ETC Model adjusts Medicare payments on certain dialysis and dialysis-related claims for participating ESRD facilities and clinicians caring for beneficiaries with ESRDor Managing Cliniciansbased on their rates of home dialysis transplant waitlisting, and living donor transplants. We believe that these two models will test ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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: 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.
Health Center Program; Announcing Period of Performance Extensions With Funding for Health Center Program Award Recipients in Las Vegas, Nevada and Washington, District of Columbia
Additional grant funds were provided to two Health Center Program award recipients in Las Vegas, Nevada and Washington, District of Columbia with periods of performance ending in fiscal year (FY) 2020 to extend their periods of performance by up to 4 months to ensure the ongoing delivery of services until a new competitive award could be made.
Implementation of Executive Order 13937, “Executive Order on Access to Affordable Life-Saving Medications”
The Department of Health and Human Services (HHS) proposes to implement the Executive Order 13937 (Executive Order) of July 24, 2020. The Executive Order requires that entities funded under section 330(e) of the Public Health Service Act (PHS Act or the Act), whether by receiving a federal award or a subaward, and who also participate in the 340B Drug Pricing Program, must establish practices to provide access to insulin and injectable epinephrine to low-income patients at the price the health center purchased these two drugs through the 340B Drug Pricing Program. The Executive Order supports the improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements. HHS is seeking public comment on this notice of proposed rulemaking (NPRM).
Informational Meeting: The Importation of Infectious Biological Agents, Infectious Substances and Vectors; Public Webinar
The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) is hosting a public webinar to address import permit regulations for infectious biological agents, infectious substances, and vectors. Besides the CDC, presenters for this webinar may include representatives from the Department of Transportation, Department of Agriculture and Department of Homeland Security.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``AHRQ Safety Program for Improving Surgical Care and Recovery.'' This proposed information collection was previously published in the Federal Register on July 28th, 2020 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; State Grants for Assistive Technology Program Annual Progress Report
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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This revision (ICR Rev) solicits comments on the information collection requirements related to the State Grants for Assistive Technology Program Annual Progress Report (AT APR).
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Health Insurance Assistance Program (SHIP) Data Performance Reports and Information Collection Tools
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the modification and use of the Data Performance Reports and Information Collection tools for the State Health Insurance Assistance Program (SHIP) under OMB 0985-0040 that expires September 30, 2020
Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention and Public Health Fund Evidence-Based Falls Prevention Program Information Collection
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 notice solicits comments on the Proposed Extension with minor changes and solicits comments on the information collection requirements related to Prevention and Public Health Funds Evidence- Based Falls Prevention Program Information Collection.
Request for Information: Viral Hepatitis National Strategic Plan 2021-2025 Available for Public Comment
The Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft Viral Hepatitis National Strategic Plan: A Roadmap to Elimination (2021-2025) (Hepatitis Plan) available for public comment. The draft Hepatitis Plan may be reviewed at www.hhs.gov/hepatitis.
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