Department of Health and Human Services October 21, 2015 – Federal Register Recent Federal Regulation Documents

The National Heart, Lung, and Blood Institute (NHBLI), a component of the National Institutes of Health (NIH) announces the ``Novel, Innovative Tools to Increase Public Awareness and Knowledge of Sickle Cell Disease Undergraduate Challenge'' to help address the lack of awareness about sickle cell disease and its associated complications and to improve successful implementation of effective interventions for sickle cell disease (SCD) in real world settings. In addition, by directing the Challenge at undergraduate students, the Challenge also aims to advance the field of implementation science through research training, mentoring, and highlighting the contributions of a new generation of undergraduate researchers using a systems science approach to address multi-faceted problems.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by our Agency. 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 of an existing collection of information and to allow 60 days for public comment. This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA).

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Administrative Practices and Procedures; Formal Evidentiary Public Hearing'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Manufacturing Site Change Supplements: Content and Submission''. This draft guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider to determine whether a preapproval inspection is necessary before approval of the PMA supplement. This draft guidance is not final nor is it in effect at this time.