Department of Health and Human Services September 2021 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 291
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: SHIP COVID-19 Testing and Mitigation Program Data Collection-New, Emergency
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.
Proposed Information Collection Activity; National Survey of Early Care and Education COVID-19 Follow-Up
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)
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)
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)
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
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
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
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.
B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch
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
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/.
Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee on Procedures Reviews (SPR), National Institute for Occupational Safety and Health (NIOSH)
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)
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/.
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
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
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)
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: https://www.cdc.gov/vaccines/acip/.
Agency Information Collection Activities: Proposed Collection; Comment Request
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
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.
Agency Father Generic Information Collection Request; 30-Day Public Comment Request
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
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.
Agency Father Generic Information Collection Request. 60-Day Public Comment Request
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.
Findings of Research Misconduct
Findings of research misconduct have been made against Ya Wang, M.D., Ph.D. (Respondent), retired Professor and Director, Division of Experimental Radiation Oncology, Department of Radiation Oncology, Winship Cancer Institute, Emory University (EU). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P30 CA138292 and R01 CA186129 and National Institute of General Medical Sciences (NIGMS), NIH, grant R01 GM080771. The administrative actions, including debarment for a period of four (4) years, were implemented beginning on August 4, 2021, and are detailed below.
Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, and also describes FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled ``Questions and Answers on Biosimilar Development and the BPCI Act'' issued December 12, 2018.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Meeting of the National Advisory Council on Migrant Health
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Council on Migrant Health (NACMH or Council) has scheduled a public meeting. Information about NACMH and the agenda for this meeting can be found on the NACMH website at: https://bphc.hrsa.gov/qualityimprovement/ strategicpartnerships/nacmh.
Agency Information Collection Request; 30-Day Public Comment Request
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Million Hearts Hospital & Health System Recognition Program. This program recognizes institutions working systematically to improve the cardiovascular health of the population and communities they serve.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Reducing Fatigue Among Taxi Drivers. The goal of the proposed collection is to evaluate two interventions, a training and a wrist-device that provides personalized daily fatigue scores, designed to enable taxi drivers to reduce their fatigue levels. This research study involves two parts: Development of a fatigue management eLearning training tool designed for drivers-for- hire (e.g., taxi drivers; ride sourcing drivers); and an evaluation of the effectiveness of this training alone and paired with the wrist- device that provides personalized daily fatigue scores.
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