Health and Human Services Grants Regulation
This final rule makes changes to the Department of Health and Human Services' (HHS) adoption of the Office of Management and Budget's (OMB) (``Uniform Administrative Requirements'') published on December 19, 2014 and the technical amendments published by HHS on January 20, 2016. HHS codified the OMB language, with noted modifications as explained in the preamble to the December promulgation. The HHS- specific modifications to the Uniform Administrative Requirements adopted prior regulatory language that was not in conflict with OMB's language, and provided additional guidance to the regulated community. Unlike all of the other modifications to the Uniform Administrative Requirements, these additional changes, although based on existing law or HHS policy, were not previously codified in regulation. HHS sought comment on these proposed changes in a notice of proposed rulemaking published on July 13, 2016. This final rule implements these regulatory changes. It also corrects one typographical error that was recently discovered in the most recent promulgation of the Uniform Administrative Requirements.
Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug Administration Staff; Availability
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.
Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Ebola Virus Disease Vaccines-Amendment
The Secretary is amending the Declaration issued pursuant to section 319F-3 of the Public Health Service Act on December 3, 2014 (79 FR 73314) and amended on December 1, 2015 (80 FR 76541) to extend the effective time period for an additional 24 months and to clarify the description of Covered Countermeasures consistent with the terms of the Declaration and republishing the Declaration in its entirety as amended.
Ebola Virus Disease Therapeutics-Amendment
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.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results 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.