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

In 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may apply for enrollment in the Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions, as well as a process to add new conditions to the List of WTC-Related Health Conditions (List). After using the regulations for a number of years, the Administrator of the WTC Health Program identified potential improvements to certain existing provisions, including, but not limited to, appeals of enrollment, certification, and treatment decisions, as well as the procedures for the addition of health conditions for WTC Health Program coverage. He also identified the need to add new regulatory provisions, including, but not limited to, standards for the disenrollment of a WTC Health Program member and decertification of a certified WTC-related health condition. A notice of proposed rulemaking was published on August 17, 2016; this action addresses public comments received on that proposed rulemaking, as well as three interim final rules promulgated since 2011, and finalizes the proposed rule and three interim final rules.

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.

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).

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.

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.

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).

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) has determined the regulatory review period for NUCALA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0001, scheduled to expire on December 31, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Food and Drug Administration (FDA) is correcting a final rule entitled ``Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs'' that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids.'' FDA is issuing this guidance to communicate to consumers, hearing aid dispensers, hearing aid manufacturers, and hearing health professionals that FDA does not intend to enforce certain conditions for sale of hearing aid devices that are required per FDA regulation. Specifically, FDA does not intend to enforce the medical evaluation or recordkeeping requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older.

The Food and Drug Administration (FDA or Agency) has determined that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium chloride, injectable, 234 mg/mL, if all other legal and regulatory requirements are met.

The Secretary is amending the February 27, 2015, Declaration issued pursuant to the Public Health Service Act and amended December 9, 2015 (80 FR 76536) to extend the effective time period for an additional 24 months consistent with the terms of the Declaration and republishing the Declaration in its entirety as amended.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. This guidance also includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate. Aside from that section, this guidance is a final guidance subsequent to the draft guidance that was issued on June 11, 2014.

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: 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.