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

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Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-24230
Type: Notice
Date: 2020-10-30
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 existing information collection project titled The Childcare Survey of Activity and Wellness (C-SAW) Pilot Study. The pilot study will determine the current practices and policies of early care and education (ECE) providers in four states around nutrition, physical activity, and wellness and will inform the development of a potential national surveillance system.
Submission for OMB Review; Information Comparison With Insurance Data (OMB #0970-0342)
Document Number: 2020-24141
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting a 3-year extension of the currently approved Information Comparison with Insurance Data (OMB #0970-0342; Expires 1/31/2021).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-24132
Type: Notice
Date: 2020-10-30
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.
Ninth Meeting of the National Clinical Care Commission
Document Number: 2020-24126
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services
The National Clinical Care Commission (the Commission) will conduct its ninth meeting virtually on November 17, 2020. The Commission is charged to evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
Decision To Evaluate a Petition To Designate a Class of Employees From the Pinellas Plant in Clearwater, Florida, To Be Included in the Special Exposure Cohort
Document Number: 2020-24123
Type: Notice
Date: 2020-10-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Pinellas Plant in Clearwater, Florida, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Radiation Exposure Screening and Education Program, OMB No. 0906-0012-Extension
Document Number: 2020-24122
Type: Notice
Date: 2020-10-30
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 Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-24081
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, And Blood Institute; Notice of Closed Meeting
Document Number: 2020-24080
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-24079
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2020-24078
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2020-24075
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services, National Institutes of Health
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Document Number: 2020-24028
Type: Notice
Date: 2020-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2023 through 2027. These comments will be published and available on FDA's website.
Sanofi-Aventis U.S. LLC, et.al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
Document Number: 2020-24012
Type: Notice
Date: 2020-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 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.
Final NIH Policy for Data Management and Sharing and Supplemental Information
Document Number: 2020-23674
Type: Notice
Date: 2020-10-30
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) is issuing this final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This Policy establishes the requirements of submission of Data Management and Sharing Plans (hereinafter Plans) and compliance with NIH Institute, Center, or Office (ICO)-approved Plans. It also emphasizes the importance of good data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. This Policy applies to research funded or conducted by NIH that results in the generation of scientific data.
Submission for OMB Review; Multistate Financial Institution Data Match With Federally Assisted State Transmitted Levy
Document Number: 2020-24008
Type: Notice
Date: 2020-10-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting a 3-year extension of the currently approved Multistate Financial Institution Data Match with Federally Assisted State Transmitted Levy (MSFIDM/FAST Levy) (current OMB approval expires 1/31/2021).
Submission for OMB Review; Administration and Oversight of the Unaccompanied Alien Children Program (0970-0547)
Document Number: 2020-24006
Type: Notice
Date: 2020-10-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR) Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow ORR to monitor Unaccompanied Alien Children (UAC) Program care provider facility compliance with Federal laws and regulations, legal agreements, and ORR policies and procedures; and perform other administrative tasks related to the UAC Program. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection. Information collections related to other aspects of the UAC Programs, such as sponsorship and health care, are covered under OMB Numbers 0970-0278, 0970-0385, 0970-0466, 0970-0490, 0970-0498, 0970-0509, and 0970-0543.
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Guidance for Industry; Availability
Document Number: 2020-23999
Type: Notice
Date: 2020-10-29
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 ``Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.'' The document provides guidance about the nonclinical information FDA recommends to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. This guidance finalizes the draft guidance of the same name issued August 6, 2018.
Office of The Director, National Institutes of Health Notice of Meeting
Document Number: 2020-23996
Type: Notice
Date: 2020-10-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute Of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23965
Type: Notice
Date: 2020-10-29
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Meeting
Document Number: 2020-23910
Type: Notice
Date: 2020-10-29
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on December 9 and 10, 2020. The purpose of the meeting is for the Committee to discuss state efforts in implementing the recommendations described in its interim report, Best Practices and Recommendations for States, as well as discuss gap areas and barriers to addressing the sex trafficking of children and youth in the United States as it relates to demand, online exploitation, interstate compacts, and other issue areas. The Committee requests any examples and comments from the public to inform their work and also requests input on barriers pertaining to the recommendations in its interim report, including strategies to ensure that policies and procedures related to interstate compacts (e.g., Interstate Compact on the Placement of Children; Interstate Commission for Juveniles), as well as the implementation of interstate compacts, work to combat the sex trafficking of children and youth; strategies for states to address demand (for the purposes of this discussion, demand reduction refers to any effort to reduce the purchase of sex from a minor); and, strategies for states to address vulnerabilities for human trafficking as it relates to online exploitation, recruitment, and grooming of children and youth, specifically as it relates to engaging with tech companies. Please submit your examples and/or comments to NAC@nhttac.org with the subject ``NAC Comments'' as soon as possible and before December 1, 2020.
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
Document Number: 2020-23340
Type: Proposed Rule
Date: 2020-10-29
Agency: Department of Health and Human Services
This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-23893
Type: Notice
Date: 2020-10-28
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.
Performance Review Board Membership
Document Number: 2020-23891
Type: Notice
Date: 2020-10-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with regulations prescribed by the Office of Personnel Management, one or more Senior Executive Service (SES) Performance Review Boards (PRBs). The PRB shall review and evaluate the initial summary rating of a senior executive's performance, the executive's response, and the higher-level official's comments on the initial summary rating. In addition, the PRB will review and recommend executive performance bonuses and pay increases.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-23890
Type: Notice
Date: 2020-10-28
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 Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23882
Type: Notice
Date: 2020-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-23881
Type: Notice
Date: 2020-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23880
Type: Notice
Date: 2020-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23879
Type: Notice
Date: 2020-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2020-23878
Type: Notice
Date: 2020-10-28
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; Information Collection Request Title: Enhancing Linkage of Sexually Transmitted Infection and Human Immunodeficiency Virus Surveillance Data in the Ryan White HIV/AIDS Program Evaluation, OMB No. 0906-New
Document Number: 2020-23871
Type: Notice
Date: 2020-10-28
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.
Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Guidance for Industry; Availability
Document Number: 2020-23848
Type: Notice
Date: 2020-10-28
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 ``Referencing Approved Drug Products in Abbreviated New Drug Application Submissions.'' Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an ANDA submission.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting
Document Number: 2020-23846
Type: Notice
Date: 2020-10-28
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 information collection provisions of the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the information collection provisions of the guidance entitled ``Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.''
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2020-23843
Type: Notice
Date: 2020-10-28
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 Cardiovascular and Renal 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.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2020-23842
Type: Notice
Date: 2020-10-28
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 Cardiovascular and Renal 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.
Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date; Immediately in Effect Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff; Availability
Document Number: 2020-23841
Type: Notice
Date: 2020-10-28
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 ``Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date.'' FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED) systems.
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies; Draft Guidance for Industry; Availability
Document Number: 2020-23840
Type: Notice
Date: 2020-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.'' The draft guidance provides information intended to assist applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence (SE) report. The draft guidance is intended to discuss a variety of scientific issues applicants may want to consider as they design and conduct TPPI studies.
The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments
Document Number: 2020-23838
Type: Notice
Date: 2020-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the following virtual public meeting entitled ``The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security.'' The purpose of the public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA and provide input on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) and the results of FDA's DSCSA Pilot Project Program.
Solicitation of Nominations for Appointment to the Lead Exposure and Prevention Advisory Committee (LEPAC)
Document Number: 2020-23804
Type: Notice
Date: 2020-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the LEPAC. The LEPAC consists of 15 Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of the committee's objectives. Nominees will be selected based on expertise in the fields of epidemiology, toxicology, mental health, pediatrics, early childhood education, special education, diet and nutrition, and environmental health. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of LEPAC objectives.
Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (STAC)
Document Number: 2020-23803
Type: Notice
Date: 2020-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, is seeking nominations for membership on the World Trade Center (WTC) Health Program STAC. The STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, mental health, and representatives of World Trade Center (WTC) responders as well as representatives of certified-eligible WTC survivors. The STAC reviews scientific and medical evidence and makes recommendations to the Administrator of the WTC Health Program on additional Program eligibility criteria and additional WTC-related health conditions, reviews and evaluates policies and procedures used to determine whether sufficient evidence exists to support adding a health condition to the List of WTC-Related Health Conditions, makes recommendations regarding individuals to conduct independent peer reviews of the scientific and technical evidence underlying a final rule adding a condition to the List of WTC-Related Health Conditions, and provides consultation on research regarding certain health conditions related to the September 11, 2001 terrorist attacks.
Charter Renewal of the Secretary's Advisory Committee on Human Research Protection
Document Number: 2020-23789
Type: Notice
Date: 2020-10-28
Agency: Department of Health and Human Services
The Department of Health and Human Services is hereby giving notice that the charter for the Secretary's Advisory Committee on Human Research Protection (SACHRP) has been renewed.
Privacy Act of 1974; System of Records
Document Number: 2020-23770
Type: Notice
Date: 2020-10-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying a system of records maintained by the Centers for Disease Control and Prevention (CDC), 09-20-0170, National Select Agent Registry (NSAR)/Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER. SATERIS is a national database registry containing the name of and location information about individuals possessing, using, or transferring select agents and toxins and characterization information about the agents and toxins, as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. HHS/CDC is changing the name of the system of records to ``Electronic Federal Select Agent Program Portal (eFSAP Portal)'' and making other updates, some of which result from an information technology (IT) system upgrade.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2020-23732
Type: Notice
Date: 2020-10-27
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Listing of Members of the Indian Health Service's Senior Executive Service Performance Review Board (PRB)
Document Number: 2020-23713
Type: Notice
Date: 2020-10-27
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a notice in the Federal Register on October 14, 2020 listing members of the Indian Health Service's Senior Executive Service Performance Review Board. The membership listing failed to include Mr. Christopher Mandregan as a member of the Performance Review Board.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-23707
Type: Notice
Date: 2020-10-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2020-23705
Type: Notice
Date: 2020-10-27
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Tick-Borne Disease Working Group
Document Number: 2020-23693
Type: Notice
Date: 2020-10-27
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will review chapters and the template for the 2020 report to the HHS Secretary and Congress. The 2020 report will address ongoing tick- borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, and interventions for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.
Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration; Availability
Document Number: 2020-23687
Type: Notice
Date: 2020-10-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a 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). The final standard MOU describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the MOU in investigating and responding to complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-23679
Type: Notice
Date: 2020-10-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-23678
Type: Notice
Date: 2020-10-27
Agency: Department of Health and Human Services, National Institutes of Health