Department of Health and Human Services December 14, 2016 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) and the National Preparedness and Response Science Board (NPRSB) will be holding a joint public teleconference.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2017 fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).

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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on ``Patient- Focused Drug Development for Sarcopenia.'' Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of sarcopenia on daily life as well as patient views on treatment approaches for sarcopenia.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Fruit Juice and Vegetable Juice as Color Additives in Food.'' The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations.

On April 11, 2016, the Administrator of the World Trade Center (WTC) Health Program received two petitions (combined into Petition 012) to add atherosclerosis to the List of WTC-Related Health Conditions (List). The Program conducted a literature search for the term in response to the Petition and found no relevant studies regarding atherosclerosis among 9/11-exposed populations. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

The Social Security Act (the Act) requires that ACF regulate a national data collection system that provides comprehensive demographic and case-specific information on children who are in foster care and adopted. This final rule replaces existing Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations and the appendices to require title IV-E agencies to collect and report data to ACF on children in out-of-home care, and who exit out-of-home care to adoption or legal guardianship, children in out-of-home care who are covered by the Indian Child Welfare Act, and children who are covered by a title IV-E adoption or guardianship assistance agreement.