Department of Health and Human Services December 21, 2020 – 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 The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs). GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications'' that appeared in the Federal Register on October 9, 2020. The document announced the withdrawal of approval (as of November 9, 2020) of nine abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771: ANDA 077788, Albuterol Sulfate Syrup, Equivalent to 2 milligrams base/5 milliliters. Before FDA withdrew the approval of this ANDA, VistaPharm, Inc., informed FDA that it did not want the approval of the ANDA withdrawn. Because VistaPharm, Inc., timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 077788 is still in effect.

The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director, National Institutes of Health (NIH) is seeking public comment regarding its proposal to transfer the Office of Nutrition Research (ONR) from the National Institute of Diabetes and Digestive and Kidney Diseases to DPCPSI in the Office of the Director, NIH. The program offices in DPCPSI share a common mission of identifying emerging scientific opportunities, rising public health challenges, or scientific knowledge gaps that deserve special emphasis. The proposed reorganization would align this important office with offices having similar trans-NIH functions.

The Food and Drug Administration (FDA, Agency, or we) 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 reporting and recordkeeping requirements of our regulations concerning new animal drugs for investigational use.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective February 1, 2021, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

This is a primary data collection request for the Follow-up Study of Coaching Practices in Early Care and Education Settings (3), 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 Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The proposed revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. FDA is proposing this action because these regulations are obsolete or no longer necessary to achieve public health goals. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive Orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.