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

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 Phased Approach to the Resumption of Passenger Operations. The proposed collection outlines a number of information collection activities required as part of the process to returning to passenger operations.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect new information to use in testing measures of the implementation and costs of high-quality early care and education as part of the project, Assessing the Implementation and Cost of High-Quality Early Care and Education (ECE-ICHQ). The study received approval for a field test to validate and improve the psychometric properties of these measures in November 2019. This request is to add a measure to the approved field test to help further assess the associations between measures of implementation, cost, and quality.

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 the information collection associated with requirements for medical device reporting for user facilities, manufacturers, importers, and distributors of medical devices.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

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 electronic user fee payment request forms.

HRSA published a document in the Federal Register of January 28, 2021, concerning a meeting of the Advisory Commission on Childhood Vaccines. The document contained incorrect dates. The date of the June 2021 Advisory Commission on Childhood Vaccines (ACCV) meeting has changed. The original date for the June 2021 ACCV meeting was June 3, 2021. The new date for the June 2021 ACCV meeting is June 18, 2021.

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder provides eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, who are state licensed and registered by the DEA to prescribe controlled substances, an exemption from certain statutory certification requirements related to training, counseling and other ancillary services (i.e., psychosocial 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. April 28, 2021.

This proposed notice acknowledges the receipt of an application from the American Diabetes Association (ADA) for continued recognition as a national accrediting organization (AO) for accrediting entities that wish to furnish diabetes outpatient self-management training services to Medicare beneficiaries.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases.'' FDA is publishing this draft guidance to help sponsor-investigators (hereafter referred to as sponsors) with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) for certain individualized antisense oligonucleotide (ASO) drug products. ASO drug products that are the focus of this draft guidance are those being developed to treat rapidly progressing, severely debilitating or life-threatening (SDLT) disease attributable to a unique genetic variant or variants that may be amenable to RNA- directed treatment.

The development of a national strategy on vector-borne diseases including tickborne diseases was mandated by Congress. To inform development of the national strategy to address vector-borne diseases, HHS is issuing this Request for Information (RFI). The RFI solicits specific input regarding strategic goals, benchmarks, gaps, duplicative federally funded programs, and opportunities to enhance coordination data collection, research, and the development of diagnostics, treatments, vaccines and other related activities across HHS and other federal departments. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.

This is a primary data collection request for the Follow-up Study of Coaching Practices in Early Care and Education Settings (Follow-up SCOPE), a follow-up to the previously approved Study of Coaching Practices in Early Care and Education Settings (SCOPE) survey (OMB #0970-0515). The study aims to examine, using surveys and qualitative interviews, the practice and processes of coaching and professional development in supporting early care and education (ECE) settings in their provision of care for preschool children and their families as COVID-19 has progressed. The study will focus on both centers and family child care (FCC) homes that serve low-income children, with a primary target of settings that serve children supported by Child Care and Development Fund subsidies or a Head Start grant.

The Office of Community Services (OCS) requests a three-year extension of the forms Community Services Block Grant (CSBG) State Plan, CSBG Eligible Entity Master List, and the American Customer Survey Index (ACSI) (OMB #0970-0382, expiration 6/30/2021). There are minimal changes requested to the State Plan and the Master List. No changes are proposed to the ACSI.

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 ``Drug Overdose Surveillance and Epidemiology''. This information collection is designed to improve local, state, and regional situational awareness of drug, opioid, heroin, and stimulant overdose trends and respond to acute local and multi-state drug outbreaks.