Department of Health and Human Services January 2020 – Federal Register Recent Federal Regulation Documents

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 voluntary customer satisfaction service surveys.

This document is a request for information (RFI) to seek public comments regarding the coordination of care from out-of-state providers for Medicaid-eligible children with medically complex conditions. We wish to identify best practices for using out-of-state providers to provide care to children with medically complex conditions; determine how care is coordinated for such children when that care is provided by out-of-state providers, including when care is provided in emergency and non-emergency situations; reduce barriers that prevent such children from receiving care from out-of-state providers in a timely fashion; and identify processes for screening and enrolling out-of-state providers in Medicaid, including efforts to streamline such processes for out-of-state providers or to reduce the burden of such processes on them. We intend to use the information received in response to this RFI to issue guidance to state Medicaid directors on the coordination of care from out-of-state providers for children with medically complex conditions.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Children's Justice Act Program Instruction (OMB #0970-0425, expiration 4/30/2020). There are no changes requested to the form.

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.

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.

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.

This proposed rule would amend the Department of Health and Human Services' (``Department'') general regulations to implement Executive Order 13831, on the Establishment of a White House Faith and Opportunity Initiative. This proposed rule proposes changes to provide clarity about the rights and obligations of faith-based organizations participating in Department programs, clarify the Department's guidance documents for financial assistance with regard to faith-based organizations, and eliminate certain requirements for faith-based organizations that no longer reflect executive branch guidance or Supreme Court precedent. This proposed rulemaking is intended to ensure that the Department's programs are implemented in a manner consistent with the requirements of federal law, including the First Amendment to the Constitution and the Religious Freedom Restoration Act.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to collect data for an evaluation of the initiative, Community Collaborations to Strengthen and Preserve Families (also referred to as Child Welfare Community Collaborations [CWCC]). The cross-site process evaluation will provide insight to ACF about the various factors that promote or impede the implementation of child welfare community collaborations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers.'' This draft guidance provides information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. Specifically, when finalized, this draft guidance will provide FDA's current thinking regarding iPSPs for oncology drugs in light of the amendments to the FD&C Act made by the FDA Reauthorization Act of 2017 (FDARA). FDA has received a number of questions on this topic and, as a result, is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.

The National Clinical Care Commission (the Commission) solicits public comments on a set of questions concerning the context, policies, effectiveness, promising practices, and limitations and gaps related to prevention and treatment of diabetes and its complications. The Commission is charged to evaluate and make recommendations to the Secretary of Health and Human Services (HHS) and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for diabetes and its complications. The set of questions is available in the SUPPLEMENTARY INFORMATION section, below.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Treatments for Acute Episodic Migraine, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.