Department of Health and Human Services September 23, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
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.
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