Department of Health and Human Services September 3, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Proposed Information Collection Activity; ORR Serious Medical Procedure Request (SMR) Form (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new data collection, the Serious Medical Procedure Request (SMR) Form.
Proposed Information Collection Activity; Understanding Children's Transitions From Head Start to Kindergarten (HS2K) (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct semi-structured, qualitative interviews with Head Start staff (grantee administrators, managers/coordinators, center directors, teachers, staff), parents, affiliated community providers, and partner Local Education Agency (LEA) staff (administrators, elementary school principals, staff, and kindergarten teachers) at six sites. A comparative case study design will explore varying strategies and approaches to supporting children's transitions from Head Start to kindergarten.
Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, entitled ``Control of Nitrosamine Impurities in Human Drugs.'' This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy to identify and minimize nitrosamines in any pharmaceutical product at risk for their presence.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Proposed Information Collection Activity; Infant and Toddler Teacher and Caregiver Competencies (ITTCC) Study (New Collection)
This is a primary data collection request for the Infant and Toddler Teacher and Caregiver Competencies (ITTCC) study to examine, using qualitative case studies, different approaches to implementing competency frameworks and assessing competencies of teachers and caregivers of infants and toddlers who work in group early care and education (ECE) settings (centers and family child care homes). Each case study will focus on a specific competency framework used by states, institutions of higher education, professional organizations, or ECE programs. This study aims to present an internally valid description of the implementation of competency frameworks and assessment of competencies for up to seven purposively selected cases, not to promote statistical generalization to different sites or service populations.
Proposed Information Collection Activity; ORR-3 and ORR-4 Report Forms for the Unaccompanied Refugee Minors Program (OMB #0970-0034)
The Office of Refugee Resettlement (ORR) is requesting a 3- year extension of the ORR-3 and ORR-4 Report Forms (OMB #0970-0034, expiration 01/31/2021). ORR proposes revisions to improve clarity, secure outcome-based data, increase compliance with reporting requirements, and reduce burden.
Submission for OMB review; 30-Day Comment Request; Specimen Resource Locator (National Cancer Institute)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
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