Department of Health and Human Services May 2021 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 291
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-10221
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-10220
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-10181
Type: Notice
Date: 2021-05-14
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; Food Safety; Federal-State Food Regulatory Program Standards
Document Number: 2021-10180
Type: Notice
Date: 2021-05-14
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 revision 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 information collection associated with FDA's Federal-State Food Regulatory Program Standards.
Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Information and Comments
Document Number: 2021-10179
Type: Notice
Date: 2021-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on evaluating the clinical pharmacology of peptides. For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides, as well as the effects of peptides on cardiac electrophysiology. However, there may be other clinical pharmacology considerations concerning the development of peptides. Public comments will help FDA develop recommendations for the design and conduct of studies important to the safe and effective use of peptides and facilitate the regulatory assessment of such studies.
Modified Risk Tobacco Product Application: Application for the IQOS 3 System Holder and Charger Submitted by Philip Morris Products S.A.
Document Number: 2021-10177
Type: Notice
Date: 2021-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of a modified risk tobacco product application (MRTPA) for the IQOS 3 System Holder and Charger submitted by Philip Morris Products S.A.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-10167
Type: Notice
Date: 2021-05-14
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 Neurological Devices Panel of the Medical Devices Advisory 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.
Determination That OVIDE (Malathion) Lotion, 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-10166
Type: Notice
Date: 2021-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that OVIDE (malathion) lotion, 0.5%, 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.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-10158
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-10157
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2021-10154
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-10153
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-10152
Type: Notice
Date: 2021-05-14
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, Nurse Fatigue-Mitigation Education: Does it Change Nurse Sleep Behavior? The purpose of this project is to evaluate the online NIOSH Training for Nurses on Shift Work and Long Work Hours for effectiveness at improving nurse sleep and well-being. Study 1 describes the nurses who have taken the training since first published on the NIOSH website in 2015. Study 2 assesses the effectiveness of the training on nurse sleep health and well-being over a six-month post-training period.
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2021-10151
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2021-10150
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-10149
Type: Notice
Date: 2021-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-10147
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-10145
Type: Notice
Date: 2021-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-10144
Type: Notice
Date: 2021-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff
Document Number: 2021-10122
Type: Rule
Date: 2021-05-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as ``nursing homes'') and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. This IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that causes COVID-19, by requiring education about COVID-19 vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and by requiring that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (CDC). These requirements are necessary to help protect the health and safety of ICF-IID clients and LTC facility residents. In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority.
CDC Draft 2021 Update to the HIV Preexposure Prophylaxis Clinical Practice Guideline and Supplement; Webinars
Document Number: 2021-10094
Type: Notice
Date: 2021-05-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces webinars that will be held on two dates to receive comments on the draft 2021 update to the HIV Preexposure Prophylaxis (PrEP) Clinical Practice Guideline and Providers Supplement. The webinars are an opportunity for all interested parties to ask questions and provide feedback, but are specifically directed toward clinicians, such as medical doctors, nurse practitioners, physician's assistants, and pharmacists. CDC will consider comments made during the webinars prior to finalizing the draft HIV Preexposure Prophylaxis Clinical Practice Guideline and Providers Supplement: 2021 Update for publication.
Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use
Document Number: 2021-10091
Type: Notice
Date: 2021-05-13
Agency: Food and Drug Administration, Department of Health and Human Services
Under the National Environmental Policy Act of 1969 (NEPA), as implemented by the Council on Environmental Quality (CEQ) regulations, the Food and Drug Administration (FDA or Agency) announces its intent to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for over-the-counter (OTC) use without prior approval of a new drug application (NDA). By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in this EIS.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Black Lung Clinics Program, OMB No. 0915-0292-Revision
Document Number: 2021-10087
Type: Notice
Date: 2021-05-13
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 Advisory Committee on Seniors and Disasters: Establishment
Document Number: 2021-10081
Type: Notice
Date: 2021-05-13
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) Office of the Secretary announces establishment of the National Advisory Committee on Seniors and Disasters (NACSD or Advisory Committee). The Advisory Committee will provide advice and recommendations to the Secretary of HHS, in accordance with the Federal Advisory Committee Act (FACA), to support and enhance all-hazards public health and medical preparedness, response activities, and recovery aimed at meeting the unique needs of seniors (older adults). The ASPR shall provide management and administrative oversight to support the activities of the Advisory Committee. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NACSD. Up to seven new voting members with expertise in senior medical disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACSD website at www.phe.gov/nacsd for all application submission information and instructions. Application submissions will be accepted for 30 calendar days from the date this posting is published in the Federal Register.
National Advisory Committee on Individuals With Disabilities and Disasters
Document Number: 2021-10080
Type: Notice
Date: 2021-05-13
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) Office of the Secretary announces establishment of the National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). The Advisory Committee will provide advice and consultation to the HHS Secretary with respect to the medical, public health, and accessibility needs of individuals with disabilities related to preparation for, response to, and recovery from all-hazards emergencies. The Office of the Assistant Secretary for Preparedness and Response (ASPR) shall provide management and administrative oversight to support the activities of the Advisory Committee. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NACIDD. Up to seven voting members with expertise disability accessibility, disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACIDD website at www.phe.gov/ nacidd for all application submission information and instructions. Application submissions will be accepted for 30 calendar days from the date this posting is published in the Federal Register.
Request for Nominations and Announcement of the Advisory Panel on Outreach and Education (APOE) May 26, 2021 Virtual Meeting
Document Number: 2021-10118
Type: Notice
Date: 2021-05-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice invites all interested parties to submit nominations to fill vacancies on the Advisory Panel on Outreach and Education (APOE). This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2021-10066
Type: Notice
Date: 2021-05-12
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 ``E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance clarifies, updates, and extends the guidance for industry ``E9 Statistical Principles for Clinical Trials'' issued in September 1998 in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The guidance is intended to better align the choice of statistical methods with questions of regulatory importance and so to improve the reliability of decisions about and representations of the effects of medical products. The guidance replaces the draft guidance issued on October 31, 2017.
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability
Document Number: 2021-10061
Type: Notice
Date: 2021-05-12
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 ``COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.'' This guidance describes FDA's current recommendations regarding phase 2 or phase 3 trials for drugs or biological products under development for the treatment or prevention of COVID-19. 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. This final guidance revises and replaces the final guidance of the same name issued on May 11, 2020. Revisions were made to address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants and the availability of COVID-19 vaccines. The revision to this guidance was posted to the FDA website on February 22, 2021.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-10050
Type: Notice
Date: 2021-05-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance \1\ related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
National Cancer Institute; Notice of Meeting
Document Number: 2021-10027
Type: Notice
Date: 2021-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2021-10026
Type: Notice
Date: 2021-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meeting
Document Number: 2021-10021
Type: Notice
Date: 2021-05-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-10020
Type: Notice
Date: 2021-05-12
Agency: Department of Health and Human Services, National Institutes of Health
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2021-10017
Type: Notice
Date: 2021-05-12
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 ``S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals.'' The 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 guidance provides key considerations for developing a testing strategy to identify hazard and characterize reproductive risk for human pharmaceuticals. The guidance is intended to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays. This guidance finalizes the draft guidance issued on November 13, 2017.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Document Number: 2021-10014
Type: Notice
Date: 2021-05-12
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public via WebEx and teleconference; a pre- registered public comment session will be held during the meeting. Pre- registration is required for members of the public who wish to attend the meeting via WebEx/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website https:// www.hhs.gov/paccarb and must be completed by June 25, 2021. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Meetings page.
Q3D(R2)-Guideline for Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2021-10011
Type: Notice
Date: 2021-05-12
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 ``Q3D(R2) Guideline for Elemental Impurities.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration and relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. In addition, error corrections to previously identified PDEs for gold (oral, parenteral, and inhalation routes), silver (parenteral route), and nickel (inhalation route) are provided. The draft guidance is intended to recommend acceptable amounts for the listed elemental impurities in pharmaceuticals for the safety of the patient and provide recommendations for conducting a risk assessment for pharmaceutical products.
Qualified Infectious Disease Product Designation-Questions and Answers; Guidance for Industry; Availability
Document Number: 2021-09986
Type: Notice
Date: 2021-05-12
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 ``Qualified Infectious Disease Product DesignationQuestions and Answers.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) created incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this final guidance is to provide a resource for information on FDA's policies and procedures related to the designation of a qualified infectious disease product (QIDP). This guidance finalizes the draft guidance of the same name issued on January 30, 2018.
Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
Document Number: 2021-09980
Type: Notice
Date: 2021-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-09973
Type: Notice
Date: 2021-05-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
Document Number: 2021-09968
Type: Notice
Date: 2021-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2021-09964
Type: Notice
Date: 2021-05-12
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 ``S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance recommends international standards for the nonclinical safety studies recommended to support the development of pediatric medicines. The guidance provides a weight of evidence approach to determine when nonclinical toxicity studies may be recommended in juvenile animals. If such studies are recommended, the guidance provides appropriate study designs. The guidance is intended to promote harmonization of recommendations for such studies and should facilitate the timely conduct of pediatric clinical trials and reduce the use of animals in accordance with the 3R (replace/reduce/refine) principles. Tissue engineered products, gene and cellular therapies, and vaccines are excluded from the scope of this guidance. The guidance replaces the draft guidance issued on February 1, 2019.
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2021-09963
Type: Notice
Date: 2021-05-12
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 ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance, which consists of a Guidance and Annexes, provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical and biotechnological/biological products. This guidance finalizes the draft guidance of the same title issued on May 31, 2018.
M9 Biopharmaceutics Classification System-Based Biowaivers; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2021-09962
Type: Notice
Date: 2021-05-12
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 ``M9 Biopharmaceutics Classification System-Based Biowaivers.'' The 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 guidance provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in vivo bioequivalence (BE) study requirement for certain drug products. The guidance is intended to avoid or reduce the need for human BE trials based on extensive in vitro characterization of the drug substance and drug product properties. The guidance replaces the existing FDA guidance issued December 26, 2017, entitled ``Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.'' The guidance also finalizes the draft ICH guidance, ``M9 Biopharmaceutics Classification System-Based Biowaivers,'' issued on October 26, 2018.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-09923
Type: Notice
Date: 2021-05-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-09915
Type: Notice
Date: 2021-05-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-09914
Type: Notice
Date: 2021-05-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-09913
Type: Notice
Date: 2021-05-11
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International Center; Notice of Meeting
Document Number: 2021-09912
Type: Notice
Date: 2021-05-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Maternal, Infant, and Early Childhood Home Visiting Program Pay for Outcomes Supplemental Information Request, OMB NO. 0906-XXXX NEW
Document Number: 2021-09910
Type: Notice
Date: 2021-05-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted a Supplemental Information Request (SIR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this SIR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-09908
Type: Notice
Date: 2021-05-11
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.