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

Results 301 - 350 of 2,570
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2021-20768
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20767
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Document Number: 2021-20754
Type: Notice
Date: 2021-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Gravity Diagnostics, LLC (Gravity) for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) (Matmacorp) for the MatMaCorp COVID-19 2SF Test, and Guardant Health Inc. (Guardant) for the Guardant-19. FDA revoked Gravity's Authorization on July 21, 2021, Matmacorp's Authorization on August 3, 2021, and Guardant's Authorization on August 6, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2021-20741
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and can be accessed via telephone or webcast only, and not in person. Agenda with call-in information and the draft report to Congress will be posted on SAMHSA's website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/ meetings. The meeting will address feedback from the ISMICC members regarding the final report to Congress and include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-20740
Type: Notice
Date: 2021-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-20733
Type: Notice
Date: 2021-09-24
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-20727
Type: Notice
Date: 2021-09-24
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-20722
Type: Notice
Date: 2021-09-24
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Advanced Nursing Education Program Specific Form OMB No. 0915-0375-Revision
Document Number: 2021-20653
Type: Notice
Date: 2021-09-24
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision
Document Number: 2021-20650
Type: Notice
Date: 2021-09-24
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.
Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
Document Number: 2021-20646
Type: Notice
Date: 2021-09-24
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 Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. Information about CHAC and the agenda for this meeting can be found on the CHAC website at https://www.cdc.gov/maso/facm/facmCHACHSPT.html and the meeting website at https://www.chacfall2021.org/.
OIG Modernization Initiative To Improve Its Publicly Available Resources-Request for Information
Document Number: 2021-20558
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, Office of Inspector General
This request for information seeks input from the public on OIG resources and how OIG could enhance the usefulness and timeliness of such resources and improve their accessibility and usability.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-20608
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-20607
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: SHIP COVID-19 Testing and Mitigation Program Data Collection-New, Emergency
Document Number: 2021-20601
Type: Notice
Date: 2021-09-23
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: 2021-20585
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-20584
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2021-20583
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-20582
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-20581
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-20580
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; National Survey of Early Care and Education COVID-19 Follow-Up
Document Number: 2021-20573
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), plans to request from the Office of Management and Budget (OMB) an extension to complete data collection for a two-wave COVID-19 Follow-up data collection currently underway as part of the National Survey of Early Care and Education (NSECE). The objective of the NSECE COVID-19 Follow-up is to document the nation's current supply of early care and education services (that is, home-based providers, center-based providers, and the center-based provider workforce). There are no changes proposed.
Submission for OMB Review; Early Head Start Family and Child Experiences Survey 2022 (Baby FACES 2022)
Document Number: 2021-20572
Type: Notice
Date: 2021-09-23
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 to continue to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2022 (Baby FACES 2022). This information collection is to provide nationally representative data on Early Head Start (EHS) programs, centers, classrooms, staff, and families to guide program planning, technical assistance, and research. This data collection will complete the previously approved second round of data collection originally planned to take place in 2020 (OMB 0970-0354). The work began in early 2020 but had to be postponed after only 3 weeks due to the COVID-19 pandemic. No changes are proposed to the currently approved information collection materials.
Proposed Information Collection Activity; Understanding the Value of Centralized Services Study (New Collection)
Document Number: 2021-20556
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing a new data collection activity as part of the Understanding the Value of Centralized Services study. The objective of this descriptive study is to understand the advantages, disadvantages, and costs of centralizing social services for individuals and families with low incomes.
Proposed Information Collection Activity; Unaccompanied Children (UC) Program Budget Workbook Template (New Collection)
Document Number: 2021-20547
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families' (ACF) Office of Refugee Resettlement (ORR) is requesting clearance for the proposed new collection titled ``UC Program Budget Workbook'' to streamline budget details and justifications of applicants to funding opportunities.
Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
Document Number: 2021-20517
Type: Notice
Date: 2021-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a draft guidance for industry #254 entitled ``Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is issuing this guidance for sponsors, firms, individuals, and establishments that participate in the manufacture of, or perform any aspect of, the donor eligibility determination for animal cells, tissues, and cell- and tissue-based products (ACTPs), which meet the definition of new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Donor eligibility is a critical component of current good manufacturing practices (CGMPs) when manufacturing ACTPs. A donor should be considered eligible to donate ACTPs only if screening of the donor shows that the donor is free from risk factors for, and clinical evidence of, infection with relevant disease agents and diseases, and the donor (and product/source material) test results for relevant disease agents are negative or nonreactive.
Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
Document Number: 2021-20514
Type: Notice
Date: 2021-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry #253 entitled ``Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is issuing this guidance to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) meeting the definition of new animal drugs with recommendations for meeting requirements for current good manufacturing practices (CGMPs). All new animal drugs, including ACTPs, are required to be manufactured in accordance with CGMPS to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics, which they purport to or are represented to possess. This guidance also provides FDA's recommendations for those aspects of manufacturing specific to ACTPs in accordance with existing CGMP regulations, as applicable, and with the FD&C Act. In this guidance, we specifically address the methods, facilities, and controls used for manufacturing ACTPs.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Bureau of Primary Health Care-Program Management Resource Compendium, 0906-XXXX, New
Document Number: 2021-20524
Type: Notice
Date: 2021-09-22
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 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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-20520
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20519
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, National Institutes of Health
B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch
Document Number: 2021-20511
Type: Notice
Date: 2021-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA110013/0032 for 6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium Chloride Injection in EXCEL[supreg] Plastic Container, held by B. Braun Medical, Inc. B. Braun Medical, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Advisory Committee on Immunization Practices (ACIP); Correction Notice of Meeting
Document Number: 2021-20478
Type: Notice
Date: 2021-09-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/index.html.
Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee on Procedures Reviews (SPR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-20477
Type: Notice
Date: 2021-09-22
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 on Procedures Reviews (SPR) 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.
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-20476
Type: Notice
Date: 2021-09-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/index.html.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2021-20468
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Opportunity To Become an Office on Women's Health (OWH) Self-Measured Blood Pressure (SMBP) Program Partner; Notice by the U.S. Department of Health and Human Services
Document Number: 2021-20456
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services' (HHS) Office on Women's Health (OWH) invites public and private sector organizations to apply to become an OWH Self-Measured Blood Pressure (SMBP) Partner. This ongoing partnership opportunity engages support from partner organizations to promote SMBP and encourages women to maintain healthy blood pressure levels at every age and stage of their lives. Through the OWH SMBP Partnership Program (``SMBP Program''), OWH seeks to increase knowledge and access to SMBP information and resources, as well as encourage organizations to address heart health disparities, prevent hypertension, promote self-measured blood pressure, and improve health equity on a community level. The SMBP Program will launch during the 2nd annual observance of National Women's Blood Pressure Awareness Week (NWBPAW), October 17-23, 2021. The SMBP Program will build on momentum generated by NWBPAW, which emphasizes the importance of blood pressure control and empowers women to improve their heart health through simple, everyday actions. Eligibility: Any organization may apply to be a SMBP Program partner. The selected SMBP Program partners may be recognized for their commitment and their work toward achieving the goals of the program. SMBP Program partners can be public and private organizations such as those at the state, local, county, and tribal levels, non- governmental organizations, non-profit organizations, businesses, academic organizations, organizations that impact health outcomes, philanthropic organizations, and tribal organizations that identify themselves as being aligned with or promoting the goals of the program. Organizations that work in areas such as fitness, nutrition, housing, health education, and those working to improve health outcomes in women may apply. Social organizations that work with, or have access to large populations of women, organizations promoting women in sports, and child-care facilities may apply. Organizations that have a defibrillator accessible onsite and are willing to make a self-measured blood pressure cuff accessible onsite, and organizations that identify themselves as being aligned with, or promoting blood pressure control are encouraged to apply. All organizations may apply. Individuals are not eligible to become an SMBP Program partner. Applicants shall submit a letter of interest and identify how they support or plan to support the SMBP Program goals. Applicants will be considered according to the organization's commitment to support those goals. SMBP Program partners may receive recognition from OWH on womenshealth.gov, girlshealth.gov, or OWH Social Media platforms. They may also receive SMBP information and resources for dissemination. The following activities may be considered as an organization's demonstrated commitment to the SMBP Program's overarching goals and objectives: Working to increase behaviors women can take to improve their heart health; Increasing access to resources and information regarding hypertension, cardiovascular disease, health risks associated with high blood pressure, and factors that increase the risk of high blood pressure; Increasing knowledge and utilization of SMBP activities (also referred to as ``self-monitoring''); Increasing understanding of blood pressure needs and understanding of blood pressure numbers; Increasing number of women collaborating with healthcare providers with a focus on self-monitoring blood pressure control, with special consideration to adapt or modify activities to meet the needs of diverse, minority, underserved, and hard to reach populations; Expanding efforts to reach those disproportionately affected by high blood pressure, including Black or African American women, Latina women, Asian/Pacific Islander women, American Indian/ Alaska Native women, women of reproductive age, women in rural communities, and women across the lifespan, to include those negatively affected by comorbidities and social determinants of health; Developing partnerships to promote SMBP across a variety of sectors, including business, community, academic, education, faith based, government, health care, media, public health, and technology; Partnering with national, state, tribal, or local volunteer organizations to provide education, training, or programs regarding health promotion, disease prevention, hypertension, SMBP, health disparities, health equity, and well-being; and/or Including information in their public facing materials about programs for hypertension, addressing SMBP, eliminating disparities, achieving health equity, and/or promoting well-being in communities. Funds: Neither HHS nor OWH will provide funds to support SMBP Program partners. Applicants, OWH, and SMBP Program partners will not be expected to contribute funds. Application: Organizations may apply to be an SMBP Program partner. Organizations should submit a letter of interest acknowledging their support of the SMBP Program's overarching goals. Organizations interested in being SMBP Program partners shall identify in their letters of interest those activities from the list noted above that demonstrate commitment to the SMBP Program's overarching goals and objectives and indicate how they address or support those goals.
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-20432
Type: Notice
Date: 2021-09-22
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 to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. 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. Following discussions with the regulated industry and consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-20473
Type: Notice
Date: 2021-09-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web. A notice of the ACIP meeting has also been posted on CDC's ACIP website: http://www.cdc.gov/vaccines/acip/index.html.
National Institute of Mental Health (NIMH); Notice of Meeting
Document Number: 2021-20424
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-20418
Type: Notice
Date: 2021-09-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the renewal of the information collection project ``Nursing Home Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on June 23rd, 2021 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Final Administrative Orders for Over-the-Counter Monographs; Availability
Document Number: 2021-20393
Type: Notice
Date: 2021-09-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of certain final administrative orders (final orders), including for over-the-counter (OTC) drug monographs, that were deemed to be final orders by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is also announcing the process for making these final orders available. Finally, FDA is announcing its plan for withdrawing regulations that established final OTC drug monographs prior to the passage of the CARES act, and withdrawing or making technical changes to the procedures governing the OTC drug review.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2021-20375
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-20374
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2021-20373
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-20372
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-20371
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-20370
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-20369
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Father Generic Information Collection Request; 30-Day Public Comment Request
Document Number: 2021-20324
Type: Notice
Date: 2021-09-21
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Import Tolerances for Residues of Unapproved New Animal Drugs in Food
Document Number: 2021-19967
Type: Rule
Date: 2021-09-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, we) is issuing a final rule that establishes procedures by which we may establish, amend, or revoke tolerances for residues of new animal drugs in any edible portion of any animal imported into the United States (import tolerances). These import tolerances provide a basis for the legal marketing of such animal-derived food.