Department of Health and Human Services 2018 – Federal Register Recent Federal Regulation Documents

This final notice announces our decision to approve the Accreditation Association for Ambulatory Health Care, Inc. for continued recognition as a national accrediting organization for ambulatory surgical centers that wish to participate in the Medicare or Medicaid programs.

The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) is proposing an extension of a currently approved generic clearance (OMB no. 0970-0477) for Grant Reviewer Recruitment (GRR) forms. The GRR forms will be used to select reviewers who will participate in the grant review process for the purpose of selecting successful applications.

HRSA is seeking nominations from organizations to send a representative to be a liaison to the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). Selections will be based on a review of the organization's subject area of expertise, mission, relevancy, and benefit provided relative to the Committee's purpose. The organizational representatives are non-voting liaisons. The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS. HRSA is seeking nominations of qualified organizations to fill up to three positions. Authority: Section 1111 of the Public Health Service (PHS) Act, as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014 (42 U.S.C. 300b-10). The Committee is governed by the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.), and 41 CFR part 102-3, which set forth standards for the formation and use of advisory committees.

The Food and Drug Administration (FDA or we) is establishing January 1, 2022, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2019, and on or before December 31, 2020. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of certain devices that demonstrate the potential to address unmet medical needs, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications (PMAs) and applied those criteria to other types of premarket submissions for medical devices. This guidance is intended to clarify certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program.

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.

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 of Diagnostic and Treatment of Clinical Alzheimer's-type Dementia (CATD), 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 Food and Drug Administration (FDA or the Agency) is announcing a new date for the public hearing to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies. FDA is also extending the comment period.

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. A 60-day Federal Register Notice was published in the Federal Register on February 21, 2018. There were 24 public comments. 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.

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.

The Office of Child Support Enforcement proposes to eliminate regulations rendered outdated or unnecessary and make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement (FEM) final rule, published on December 20, 2016, including proposing to amend the compliance date for review and adjustment of child support orders. We are also proposing conforming amendments to the regulations as a result of Bipartisan Budget Act of 2018, Public Law 115-123.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.'' This draft guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray systems and their major components. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of ``electronic products,'' as defined in FDA regulations. This draft guidance, when finalized, will supersede FDA's guidance entitled ``Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment.'' This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or we) is confirming the effective date of October 26, 2018, for the final rule that appeared in the Federal Register of September 25, 2018, and that amended the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.

This notice requests nominations for individuals to serve on the Advisory Panel on Outreach and Education (APOE).