Department of Health and Human Services September 29, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 24 of 24
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.
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