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

Results 201 - 250 of 54,073
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2020-10499
Type: Notice
Date: 2020-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-10498
Type: Notice
Date: 2020-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-10497
Type: Notice
Date: 2020-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-10496
Type: Notice
Date: 2020-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2020-10495
Type: Notice
Date: 2020-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2020-10494
Type: Notice
Date: 2020-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Enforcement Discretion Regarding COVID-19 Community-Based Testing Sites (CBTS) During the COVID-19 Nationwide Public Health Emergency
Document Number: 2020-09099
Type: Rule
Date: 2020-05-18
Agency: Department of Health and Human Services
This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As a matter of enforcement discretion, the HHS Office for Civil Rights (OCR) will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers or their business associates in connection with the good faith participation in the operation of a COVID-19 Community-Based Testing Site (CBTS) during the COVID-19 nationwide public health emergency.
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability
Document Number: 2020-10492
Type: Notice
Date: 2020-05-15
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 entitled ``Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.'' On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of SARS-CoV-2 testing. This guidance was revised on March 16, 2020, May 4, 2020, and May 11, 2020. The guidance describes four policies intended to help facilitate the development and use of SARS-CoV-2 tests during the public health emergency: Two policies for accelerating the development of certain laboratory tests for COVID-19one leading to an Emergency Use Authorization (EUA) submission to FDA and the other not leading to an EUA submission when the test is developed under the authorities of the State in which the laboratory resides and the State takes responsibility for COVID-19 testing by laboratories in its State; a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostics to laboratories for specimen testing after validation while an EUA submission is being prepared for submission to FDA; and a policy regarding the use of serological testing. In addition, FDA has included a reference to the availability, on FDA's website, of templates for commercial manufacturers and laboratories intended to facilitate EUA submissions for molecular, antigen, and serology tests. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories
Document Number: 2020-10461
Type: Notice
Date: 2020-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on personnel performing bioinformatics activities in clinical and public health laboratories; storage and retention of next generation sequencing (NGS) data files; and maintenance of sequence analysis software. The comments will be used by the Clinical Laboratory Improvement Advisory Committee (CLIAC) for deliberation and possible recommendations about future changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.
Meeting of the Advisory Committee on Infant Mortality
Document Number: 2020-10447
Type: Notice
Date: 2020-05-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisory-committees/infant-mortality/ind ex.html.
Tribal Consultation Meetings
Document Number: 2020-10440
Type: Notice
Date: 2020-05-15
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to the Head Start Act, notice is hereby given of three 1-day tribal consultation sessions to be held between HHS/ACF OHS leadership and the leadership of tribal governments operating Head Start and Early Head Start programs. The purpose of these consultation sessions is to discuss ways to better meet the needs of American Indian and Alaska Native (AIAN) children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations. Three tribal consultations will be held as part of HHS/ACF or ACF Tribal Consultation Sessions. Please note the planned tribal consultation dates may be impacted by COVID-19 travel restrictions. OHS will consider virtual means of facilitating tribal consultations and/or the postponing of tribal consultations should travel restrictions and group meeting limitations remain in effect.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2020-10429
Type: Notice
Date: 2020-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Healthcare Infection Control Practices Advisory Committee (HICPAC); Cancellation of Meeting
Document Number: 2020-10417
Type: Notice
Date: 2020-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-10412
Type: Notice
Date: 2020-05-15
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 Infant Feeding Practices Study III to understand the current state of mothers' intentions, behaviors, feeding decisions, and practices from pregnancy through their child's first two years of life and how these change.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-10411
Type: Notice
Date: 2020-05-15
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 Investigation of SARS-CoV-2 Seroprevalence and Factors Associated with Seropositivity in a Community Setting. CDC will, at the request of state and local health departments, collect epidemiological data and blood samples from households to determine the extent of COVID-19 infection in communities as determined by overall SARS-CoV-2 seroprevalence.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-10410
Type: Notice
Date: 2020-05-15
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 ``Emerging Infections Program (EIP) Tracking of SARS-CoV-2 Infections among Healthcare Personnel''. Through this project, EIP staff will collect data to: (1) Determine the extent of COVID-19 among HCP working in U.S. healthcare facilities; (2) describe characteristics of HCP exposed to or infected with SARS-CoV-2, including clinical activities and personal protective equipment use; and (3) compare exposures and other characteristics of HCP cases and exposed HCP that do not become cases to identify risk factors or protective factors for COVID-19.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-10409
Type: Notice
Date: 2020-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-10408
Type: Notice
Date: 2020-05-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Minority Health and Health Disparities; Notice of Closed Meetings
Document Number: 2020-10390
Type: Notice
Date: 2020-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-10389
Type: Notice
Date: 2020-05-15
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: 2020-10388
Type: Notice
Date: 2020-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-10387
Type: Notice
Date: 2020-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-10386
Type: Notice
Date: 2020-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Practice and Procedures
Document Number: 2020-10384
Type: Notice
Date: 2020-05-15
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products
Document Number: 2020-10373
Type: Notice
Date: 2020-05-14
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.
Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications
Document Number: 2020-10367
Type: Notice
Date: 2020-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 new drug applications (NDAs) 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; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Document Number: 2020-10359
Type: Notice
Date: 2020-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 the requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
Document Number: 2020-10353
Type: Notice
Date: 2020-05-14
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
Document Number: 2020-10351
Type: Notice
Date: 2020-05-14
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 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 information collection provisions of FDA's third-party disclosure and recordkeeping requirements for reportable food.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2020-10336
Type: Notice
Date: 2020-05-14
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.
National Advisory Committee on Children and Disasters: Establishment
Document Number: 2020-10323
Type: Notice
Date: 2020-05-14
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 Children and Disasters (NACCD). The Advisory Committee will provide advice and consultation to the HHS Secretary on pediatric medical disaster planning, preparedness, response, and recovery with respect to the medical and public health needs of children in relation to disasters. 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 NACCD. Up to 13 new voting members with expertise in pediatric medical disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACCD website at www.phe.gov/naccd 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. Application Period: The application period is from midnight (Eastern Time) May 27th-June 27th.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-10308
Type: Notice
Date: 2020-05-14
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mono-Specific Chimeric Antigen Receptor (CAR) Therapies for the Treatment of Cluster of Differentiation 33 (CD33) Expressing Malignancies
Document Number: 2020-10304
Type: Notice
Date: 2020-05-14
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer 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 practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Vor Biopharma Inc. (``Vor''), located in Cambridge, MA.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Logic-Gated Chimeric Antigen Receptor (CAR) Therapies for the Treatment of Cluster of Differentiation 33 (CD33) Expressing Cancers
Document Number: 2020-10303
Type: Notice
Date: 2020-05-14
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer 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 practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Senti Bio (``Senti''), located in South San Francisco, CA.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-10282
Type: Notice
Date: 2020-05-14
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.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans
Document Number: 2020-10045
Type: Rule
Date: 2020-05-14
Agency: Department of Health and Human Services
This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It also finalizes changes related to essential health benefits and will provide states with additional flexibility in the operation and establishment of Exchanges. The rule includes changes related to cost sharing for prescription drugs; notice requirements for excepted benefit health reimbursement arrangements offered by non- Federal governmental plan sponsors; Exchange eligibility and enrollment; exemptions from the requirement to maintain coverage; quality rating information display standards for Exchanges; and other related topics. This final rule also repeals regulations relating to the Early Retiree Reinsurance Program.
Food Additives Permitted in Feed and Drinking Water of Animals; Spent Bleaching Clay
Document Number: 2020-10035
Type: Proposed Rule
Date: 2020-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending a notice of petition announcing that the Canadian Oilseed Processors Association has filed a petition proposing that the food additive regulations be amended to provide for the safe use of spent bleaching clay as a flow agent in canola meal for all livestock and poultry species. Additionally, the petition proposes that the regulations be amended to provide for the safe use of silicon dioxide and diatomaceous earth as components of spent bleaching clay. At our request, a revised environmental assessment (EA) has been placed in the docket for public review and comment.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH) National Firefighter Registry Subcommittee; Amended Notice of Meeting
Document Number: 2020-10283
Type: Notice
Date: 2020-05-13
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 of the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH), National Firefighter Registry Subcommittee. This meeting is open to the public via webcast and by teleconference. If you wish to attend by webcast or teleconference, please register at the NIOSH website https:/ /www.cdc.gov/niosh/bsc/nfrs/registration.html or call (513-841-4203) at least five business days in advance of the meeting. Adobe Connect webcast will be available at https://odniosh.adobeconnect.com/nfrs/ for participants wanting to connect remotely, and teleconference is available toll-free at (855) 644-0229, Participant Pass Code 9777483. This meeting is open to the public, limited only by the number of adobe license seats available, which is 100. The public is welcome to participate during the public comment period, from 11:15 a.m. to 12:00 p.m., EDT, on May 15, 2020. Please note that the public comment period ends at the time indicated above.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-10281
Type: Notice
Date: 2020-05-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
Document Number: 2020-10272
Type: Notice
Date: 2020-05-13
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 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 information collection provisions of FDA's guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2020-10271
Type: Notice
Date: 2020-05-13
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: 2020-10270
Type: Notice
Date: 2020-05-13
Agency: Department of Health and Human Services, National Institutes of Health
Findings of Research Misconduct
Document Number: 2020-10253
Type: Notice
Date: 2020-05-13
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made against Dr. Shin-Hee Kim (Respondent), who was an Assistant Professor of Veterinary Medicine, University of Maryland (UMD). Dr. Kim engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R21 AI100195 and ZIA AI000938 and contract N01 AO60009. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on March 27, 2020, and are detailed below.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration, OMB No. 0915-0379-Extension
Document Number: 2020-10247
Type: Notice
Date: 2020-05-13
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 an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
Submission for OMB Review; 2020 Residential Energy Consumption Survey (RECS), Low Income Home Energy Assistance Program (LIHEAP) Administrative Data Matching (OMB #0970-0486)
Document Number: 2020-10230
Type: Notice
Date: 2020-05-13
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Community Services (OCS) is requesting a reinstatement without change for the collection and reporting of administrative household recipient data from state LIHEAP grantees. OMB approved the original collection under #0970-0486. ACF published a Federal Register notice on July 30, 2019 soliciting 60 days of public comment on requiring state grantees to provide household-level recipient data for this effort. ACF received no comments on that notice.
National Biodefense Science Board
Document Number: 2020-10156
Type: Notice
Date: 2020-05-13
Agency: Department of Health and Human Services
The National Biodefense Science Board (NBSB) is authorized under Section 319M of the Public PHS Act, as added by Section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act. The Board is governed by the Federal Advisory Committee, which sets forth standards for the formation and use of advisory committees. The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Background: The May 13, 2020, NBSB public teleconference is dedicated to the discussion of recommendations on two topics: (1) NBSB Rapid medical countermeasures (MCM) for Disease X and (2) Integrating Clinical Disaster Response Training with Community and State Based Emergency Planning. We will post modifications to the agenda and/or topics on the NBSB meeting website, which is located at https:// www.phe.gov/nbsb. Availability of Materials: We will post all teleconference materials prior to the teleconference on May 13, 2020, on the website located at https://www.phe.gov/nbsb. Procedures for Providing Public Input: Members of the public may attend the public teleconference via a toll-free call-in phone number, which is available on the NBSB website at https://www.phe.gov/nbsb.
Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
Document Number: 2020-10146
Type: Notice
Date: 2020-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, document. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Faculty Loan Program-Program Specific Data Form and Annual Performance Report Financial Data Form OMB No. 0915-0314-Revision
Document Number: 2020-10134
Type: Notice
Date: 2020-05-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR have been provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2020-10133
Type: Notice
Date: 2020-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2020-10127
Type: Notice
Date: 2020-05-12
Agency: Department of Health and Human Services, National Institutes of Health