Department of Health and Human Services December 20, 2018 – Federal Register Recent Federal Regulation Documents

Proposed Information Collection Activity; ACF's Generic Clearance for Grant Reviewer Recruitment Forms (OMB #0970-0477)
Document Number: 2018-27551
Type: Notice
Date: 2018-12-20
Agency: Department of Health and Human Services, Administration for Children and Families
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.
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period
Document Number: 2018-27519
Type: Proposed Rule
Date: 2018-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of November 15, 2018. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Solicitation of Nominations for Organizational Representatives to the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2018-27518
Type: Notice
Date: 2018-12-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information
Document Number: 2018-27506
Type: Proposed Rule
Date: 2018-12-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information (RFI) seeks public comment regarding the appropriateness of the practices of some Medicare- approved Accrediting Organizations (AOs) to provide fee-based consultative services for Medicare-participating providers and suppliers as part of their business model. We wish to determine whether AO practices of consulting with the same facilities which they accredit under their CMS approval could create actual or perceived conflicts of interest between the accreditation and consultative entities. We intend to consider information received in response to this RFI to assist in future rulemaking.
Uniform Compliance Date for Food Labeling Regulations
Document Number: 2018-27429
Type: Rule
Date: 2018-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
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.
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