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

Meeting of the National Advisory Committee on Children and Disasters and the National Preparedness and Response Science Board
Document Number: 2016-30049
Type: Notice
Date: 2016-12-14
Agency: Department of Health and Human Services
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2016-30035
Type: Notice
Date: 2016-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2017
Document Number: 2016-30034
Type: Notice
Date: 2016-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
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).
Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program
Document Number: 2016-30033
Type: Rule
Date: 2016-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-30024
Type: Notice
Date: 2016-12-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payment
Document Number: 2016-30016
Type: Rule
Date: 2016-12-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period implements new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. These requirements apply to dialysis facilities that make such payments directly, through a parent organization, or through a third party. These requirements are intended to protect patient health and safety; improve patient disclosure and transparency; ensure that health insurance coverage decisions are not inappropriately influenced by the financial interests of dialysis facilities rather than the health and financial interests of patients; and protect patients from mid-year interruptions in coverage.
Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments
Document Number: 2016-29998
Type: Notice
Date: 2016-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-29989
Type: Notice
Date: 2016-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Public Notification of Emerging Postmarket Medical Device Signals (`Emerging Signals').'' FDA is issuing this guidance to describe the Center for Devices and Radiological Health's (CDRH) policy for notifying the public about medical device ``emerging signals.'' This guidance describes the factors CDRH intends to consider in deciding whether to notify the public about an emerging signal and the processes and timelines it intends to follow in issuing and updating the notification. Timely notification about those emerging signals based on the factors described in this guidance document is intended to provide health care providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices so that they can make informed patient management decisions about their treatment and diagnostic options.
Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Availability
Document Number: 2016-29968
Type: Proposed Rule
Date: 2016-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Notice of Meeting Center for Mental Health Services
Document Number: 2016-29949
Type: Notice
Date: 2016-12-14
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
World Trade Center Health Program; Petition 012-Atherosclerosis; Finding of Insufficient Evidence
Document Number: 2016-29816
Type: Proposed Rule
Date: 2016-12-14
Agency: Department of Health and Human Services
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.
Announcement of Requirements and Registration for “Privacy Policy Snapshot Challenge”
Document Number: 2016-29718
Type: Notice
Date: 2016-12-14
Agency: Department of Health and Human Services
The Model Privacy Notice (MPN) is a voluntary, openly available resource designed to help health technology developers who collect digital health data clearly convey information about their privacy and security policies to their users. Similar to a nutrition facts label, the MPN provides a snapshot of a product's existing privacy practices, encouraging transparency and helping consumers make informed choices when selecting products. The MPN does not mandate specific policies or substitute for more comprehensive or detailed privacy policies. The Privacy Policy Snapshot Challenge is a call for designers, developers, and health data privacy experts to create an online MPN generator. The statutory authority for this Challenge is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
Adoption and Foster Care Analysis and Reporting System
Document Number: 2016-29366
Type: Rule
Date: 2016-12-14
Agency: Department of Health and Human Services, Administration for Children and Families
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.