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

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees to provide recommendations on requests submitted under the SIA regarding nonprescription sunscreen active ingredients and the number of requests to be considered per meeting. The recommendations in this guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective (GRASE) for use under specified conditions and should be included in the over-the- counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is not required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this guidance pursuant to the SIA, which directs FDA to issue guidance on four topics, including the topic discussed in this guidance. This guidance finalizes the draft guidance on the same topic issued on November 23, 2015.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter (OTC) home use by lay-users. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types.

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.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Office of Personnel Management (OPM).

The National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on the redesign of the National Health Interview Survey (NHIS) questionnaire (OMB Control No. 0920-0214, expires 01/31/2019) Any proposed changes will be submitted in future notices in compliance with the Paperwork Reduction Act (PRA). The content and structure of the NHIS will be updated in 2018 to improve the measurement of covered health topics, reduce respondent burden by shortening the length of the questionnaire, harmonize overlapping content with other federal health surveys, establish a long-term structure of ongoing and periodic topics, and incorporate advances in survey methodology and measurement.

The Food and Drug Administration (FDA or the Agency) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the rule adds 24 entries to this list of drug products, modifies the description of one entry on this list, and revises the list's title and introductory language. These revisions are necessary because information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule.