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

Results 151 - 200 of 237
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2021-17066
Type: Notice
Date: 2021-08-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-17045
Type: Notice
Date: 2021-08-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Center for Scientific Review; Notice of Meeting
Document Number: 2021-17043
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments
Document Number: 2021-17041
Type: Notice
Date: 2021-08-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between September 2, 2020, and September 2, 2021, on FDA's website but not presented at the September 17, 2021, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2021 Performance Review Board (PRB)
Document Number: 2021-17039
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2021 Performance Review Board.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-17012
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Multi-Domain Amphipathic Helical Peptide for Use as A Human Therapeutic in Patients With Atherosclerotic Cardiovascular Disease, Including Patients Undergoing Cardiovascular Surgery Who Are at risk of Acute Kidney Injury
Document Number: 2021-17011
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung, and Blood Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Phyxius Therapeutics, Inc., a start-up company incorporated as a C corporation under the laws of the state of Delaware, to practice the inventions covered by the patent estate listed in the Supplementary Information section of this notice. This is a first notice intended to apprise the public of a change in prospective licensee of the subject intellectual property rights in the stated field of use.
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-16984
Type: Notice
Date: 2021-08-10
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 Pediatric Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Submission for OMB Review; Survey of the National Survey of Child and Adolescent Well-Being (NSCAW) Adopted Youth, Young Adults, and Adoptive Parents (0970-0555)
Document Number: 2021-16979
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for an extension with no changes to a one-time study to examine familial outcomes 8 years or more after a child's adoption from the child welfare system. The primary objective of this study is to estimate the prevalence of instability events that occur in families who have adopted children who have exited the foster care system. The second objective is to understand risk and protective factors associated with post adoption instability. Office of Management and Budget (OMB) approval expires September 30, 2021, and this request is to extend approval to allow for the completion of data collection.
Notice of Final Issuance on the Administration for Native Americans Program Policies and Procedures
Document Number: 2021-16959
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to section 814 of the Native American Programs Act of 1974 (NAPA), as amended, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. On February 19, 2021, ANA published a Notice of Public Comment (NOPC) in the Federal Register regarding its proposed interpretive rules and general statements of policy relative to its six FY 2021 Funding Opportunity Announcements (FOAs): Environmental Regulatory Enhancement (HHS-2021-ACF-ANA-NR-1907); Native American Language Preservation and MaintenanceEsther Martinez Immersion (HHS-2021-ACF-ANA-NB-1958); Native American Language Preservation and Maintenance (HHS-2021-ACF-ANA-NL-1924); Social and Economic Development Strategies (HHS-2021-ACF-ANA-NA-1906); Social and Economic Development StrategiesAlaska (HHS-2021-ACF-ANA-NK-1902); and Social and Economic StrategiesGrowing Organizations (HHS-2021-ACF- ANA-NN-1918). This Notice of Issuance responds to the public comments received from the NOPC.
Most Favored Nation (MFN) Model
Document Number: 2021-16886
Type: Proposed Rule
Date: 2021-08-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule proposes to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.
Submission for OMB Review; 30-Day Comment Request; Inclusion Enrollment Report Form Conversion to Common Form, Office of the Director (OD)
Document Number: 2021-17037
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Submission for OMB Review; 30-Day Comment Request; PHS Applications and Pre-Award Related Reporting (Office of the Director)
Document Number: 2021-17031
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Meeting: Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee for Dose Reconstruction Reviews (SDRR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-16954
Type: Notice
Date: 2021-08-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Dose Reconstruction Reviews (SDRR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2021-16952
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-16951
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-16950
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments
Document Number: 2021-16944
Type: Notice
Date: 2021-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing that implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021) is expected to require some approved products to transition from drug status to device status. This notice provides information for stakeholders and solicits public comment to inform the Agency's deliberations about products potentially impacted by the Genus decision and the way in which impacted products should be transitioned from drug to device status.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2021-16942
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out of State Distribution of Compounded Human Drug Products
Document Number: 2021-16937
Type: Notice
Date: 2021-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the period for States to decide whether to sign the final standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration'' (final standard MOU) before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the final standard MOU. FDA is extending the period, which was scheduled to end on October 27, 2021, to October 27, 2022. States may sign the final standard MOU at any time, including after the period is scheduled to end on October 27, 2022.
Development and Submission of Near Infrared Analytical Procedures; Guidance for Industry; Availability
Document Number: 2021-16930
Type: Notice
Date: 2021-08-09
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 ``Development and Submission of Near Infrared Analytical Procedures.'' This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files. This guidance finalizes the draft guidance of the same title issued on March 31, 2015.
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials; Guidance for Industry; Availability
Document Number: 2021-16929
Type: Notice
Date: 2021-08-09
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 ``Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.'' Recent approvals of several drug products for patients with nonmetastatic castration-resistant prostate cancer have been supported by randomized clinical trials demonstrating improvements in metastasis-free survival. This guidance intends to inform potential future applicants regarding the Agency's expectations for collection, analysis, and reporting of data pertaining to metastasis-free survival. This guidance finalizes the draft guidance of the same title issued on November 14, 2018.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2021-16914
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-16904
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-16903
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-16901
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Substance Abuse and Mental Health Services Administration's National Advisory Council
Document Number: 2021-16891
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meeting on August 30, 2021 of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). The meeting is open to the public and can only be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include remarks and discussion with the new Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous SAMHSA NAC meeting; new grant opportunities and initiatives, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Centers for Independent Living Program Performance Report (0985-0061)
Document Number: 2021-16752
Type: Notice
Date: 2021-08-09
Agency: Department of Health and Human Services
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 Proposed Extension without Revision of a Currently Approved Collection (ICR Ext) solicits comments on the information collection requirements relating to the Centers for Independent Living under the Rehabilitation Act of 1973.
Temporary Halt in Residential Evictions in Communities With Substantial or High Transmission of COVID-19 To Prevent the Further Spread of COVID-19
Document Number: 2021-16945
Type: Notice
Date: 2021-08-06
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 a new Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions in communities with substantial or high transmission of COVID-19 to prevent the further spread of COVID-19.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-16866
Type: Notice
Date: 2021-08-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-16865
Type: Notice
Date: 2021-08-06
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 (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.
National Eye Institute; Notice of Closed Meeting
Document Number: 2021-16863
Type: Notice
Date: 2021-08-06
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director)
Document Number: 2021-16849
Type: Notice
Date: 2021-08-06
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Request for Public Comment: 60 Day Notice for Extension of the Indian Health Service Loan Repayment Program (LRP)
Document Number: 2021-16837
Type: Notice
Date: 2021-08-06
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0014, titled, ``IHS Loan Repayment Program (LRP).''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-16825
Type: Notice
Date: 2021-08-06
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 the Understanding important issues in ovarian cancer survivorship (OCS) project. The OCS project aims to better understand the needs of ovarian cancer survivors and how to more effectively develop interventions targeted to this population.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-16824
Type: Notice
Date: 2021-08-06
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 ``Performance Monitoring of CDC's Comprehensive Suicide Prevention Program''. The proposed collection will allow award recipients to report progress and activity information to CDC on an annual schedule using a web-based Partners' Portal.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-16822
Type: Notice
Date: 2021-08-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-16821
Type: Notice
Date: 2021-08-06
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 The National Violent Death Reporting System (NVDRS). NVDRS is a state-based surveillance system developed to monitor the occurrence of violent deaths in the United States.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-16803
Type: Notice
Date: 2021-08-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16797
Type: Notice
Date: 2021-08-06
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.
Public Health Reassessment and Order Suspending the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists
Document Number: 2021-16856
Type: Notice
Date: 2021-08-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces an Order to replace and supersede the Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists, issued on October 13, 2020 (``October Order''). Following an assessment of the current status of the COVID-19 public health emergency and the situation in congregate settings where noncitizens seeking to enter the United States are processed and held, CDC has determined that an Order remains appropriate at this time for all ``covered noncitizens'' as defined in the order. Unaccompanied noncitizen children, already excepted under a July 16, 2021 order, remain excepted from the order's coverage. In addition, CDC is continuing an exception for individuals on a case-by-case basis, based on the totality of the circumstances, and is incorporating an additional exception for programs approved by the U.S. Department of Homeland Security (DHS) that incorporate appropriate COVID-19 mitigation protocols as recommended by CDC.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16755
Type: Notice
Date: 2021-08-05
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.
Draft NTP Developmental and Reproductive Toxicity Technical Reports on 2-Hydroxy-4-methoxybenzophenone and 2-Ethylhexyl p-Methoxycinnamate; Availability of Documents; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2021-16734
Type: Notice
Date: 2021-08-05
Agency: Department of Health and Human Services, National Institutes of Health
The Division of the National Toxicology Program (DNTP) announces the availability of the Draft NTP Developmental and Reproductive Toxicity Technical Reports on 2-hydroxy-4- methoxybenzophenone and 2-ethylhexyl p-methoxycinnamate scheduled for peer review. The peer-review meeting will be held remotely and will be available to the public for veiwing. Oral and written comments will be accepted; registration is required to access the webcast and to present oral comments.
Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design; Public Workshop
Document Number: 2021-16709
Type: Notice
Date: 2021-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.'' The purpose of the public workshop is to discuss applications of complex and innovative trial designs in pediatric clinical trials.
Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability
Document Number: 2021-16705
Type: Notice
Date: 2021-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA has issued one Authorization for a biological product as requested by GlaxoSmithKline LLC and one Authorization for a biological product as requested by Genentech, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV- 2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
Document Number: 2021-16700
Type: Notice
Date: 2021-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
Document Number: 2021-16695
Type: Notice
Date: 2021-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Remanufacturing of Medical Devices.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Determination That VOTRIENT (Pazopanib Hydrochloride) Tablets, 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-16692
Type: Notice
Date: 2021-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that VOTRIENT (pazopanib hydrochloride) tablets, 400 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pazopanib hydrochloride tablets, 400 mg, if all other legal and regulatory requirements are met.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-16668
Type: Notice
Date: 2021-08-05
Agency: Department of Health and Human Services, National Institutes of Health
Eighth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
Document Number: 2021-16681
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to clarify and expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.